Group Quality e-Systems Key Expert
Group Quality e-Systems Key Expert
Miejsce pracy: Duchnice (pow. warszawski zachodni)
Your responsibilities- Manage the Quality Management System (QMS) for e-systems: Oversee the development, implementation, and maintenance of the QMS, ensuring alignment with regulatory requirements, industry standards, and company policies;
- Serve as Subject Matter Expert (SME): Act as the primary point of contact and SME during regulatory inspections and audits, providing support and guidance on e-systems compliance matters;
- Project Management: Lead and execute small to medium-scale projects related to e-systems quality initiatives, including system upgrades, process improvements, and validation activities;
- Documentation Control: Ensure the accuracy, completeness, and integrity of documentation within the QMS, including policies, procedures, work instructions, and other relevant documents;
- Change Management: Manage change control processes for e-systems, including assessment, approval, and implementation of changes to ensure compliance with regulatory requirements;
- Training and Communication: Provide training and support to staff on QMS procedures, processes, and compliance requirements, and communicate updates and changes effectively across the organization;
- Risk Management: Conduct risk assessments and collaborate with stakeholders to identify and mitigate risks associated with e-systems and QMS processes;
- Continuous Improvement: Drive continuous improvement initiatives within the QMS, identifying opportunities for optimization, efficiency gains, and enhanced compliance;
- Collaboration: Collaborate with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Operations, to ensure alignment of QMS processes with overall quality objectives and business needs;
- Documentation and Reporting: Maintain accurate and up-to-date records, generate reports as necessary, and provide metrics and insights on QMS performance to management and stakeholders.
- Manage the Quality Management System (QMS) for e-systems: Oversee the development, implementation, and maintenance of the QMS, ensuring alignment with regulatory requirements, industry standards, and company policies;
- Serve as Subject Matter Expert (SME): Act as the primary point of contact and SME during regulatory inspections and audits, providing support and guidance on e-systems compliance matters;
- Project Management: Lead and execute small to medium-scale projects related to e-systems quality initiatives, including system upgrades, process improvements, and validation activities;
- Documentation Control: Ensure the accuracy, completeness, and integrity of documentation within the QMS, including policies, procedures, work instructions, and other relevant documents;
- Change Management: Manage change control processes for e-systems, including assessment, approval, and implementation of changes to ensure compliance with regulatory requirements;
- Training and Communication: Provide training and support to staff on QMS procedures, processes, and compliance requirements, and communicate updates and changes effectively across the organization;
- Risk Management: Conduct risk assessments and collaborate with stakeholders to identify and mitigate risks associated with e-systems and QMS processes;
- Continuous Improvement: Drive continuous improvement initiatives within the QMS, identifying opportunities for optimization, efficiency gains, and enhanced compliance;
- Collaboration: Collaborate with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Operations, to ensure alignment of QMS processes with overall quality objectives and business needs;
- Documentation and Reporting: Maintain accurate and up-to-date records, generate reports as necessary, and provide metrics and insights on QMS performance to management and stakeholders.
Our requirements- At least 5 years of experience in a medicinal products manufacturing with strong experience in the field of compliance, various scale project management, knowledge of IT processes and systems;
- Master’s or doctoral degree in one of the fields of biology, pharmacy, biotechnology, chemistry, chemical technology, chemical and process engineering, or completed university studies in medicine;
- Knowledge of GMP requirements and regulations regarding pharmaceutical products with a focus on computerized systems validation (CSV) principles and methodologies;
- Experience in implementation and management of quality systems in the pharmaceutical industry;
- Experience in implementation of e-Systems in regulated in the pharmaceutical industry;
- Fluent in Polish and English spoken and written;
- Strong organizational and project management skills to be able to set up inspection readiness and compliance improvement programs;
- High leadership and communication skills. Ability to make decisions;
- Managerial maturity and the ability to think strategically and analytically;
- Organizational skills and the ability to work under pressure.
- At least 5 years of experience in a medicinal products manufacturing with strong experience in the field of compliance, various scale project management, knowledge of IT processes and systems;
- Master’s or doctoral degree in one of the fields of biology, pharmacy, biotechnology, chemistry, chemical technology, chemical and process engineering, or completed university studies in medicine;
- Knowledge of GMP requirements and regulations regarding pharmaceutical products with a focus on computerized systems validation (CSV) principles and methodologies;
- Experience in implementation and management of quality systems in the pharmaceutical industry;
- Experience in implementation of e-Systems in regulated in the pharmaceutical industry;
- Fluent in Polish and English spoken and written;
- Strong organizational and project management skills to be able to set up inspection readiness and compliance improvement programs;
- High leadership and communication skills. Ability to make decisions;
- Managerial maturity and the ability to think strategically and analytically;
- Organizational skills and the ability to work under pressure.
What we offer- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Relocation package;
- Additional free day;
- and more. .
- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Relocation package;
- Additional free day;
- and more. .
Benefits- sharing the costs of sports activities
- private medical care
- sharing the costs of professional training & courses
- life insurance
- remote work opportunities
- flexible working time
- fruits
- integration events
- retirement pension plan
- coffee / tea
- extra social benefits
- pre-paid cards
- holiday funds
- redeployment package
- employee referral program
- charity initiatives
- extra leave
- sharing the costs of sports activities
- private medical care
- sharing the costs of professional training & courses
- life insurance
- remote work opportunities
- flexible working time
- fruits
- integration events
- retirement pension plan
- coffee / tea
- extra social benefits
- pre-paid cards
- holiday funds
- redeployment package
- employee referral program
- charity initiatives
- extra leave
Polpharma Biologics
Polpharma Biologics is the trusted developer & manufacturer of biosimilars.
We are an international company, with integrated operations in the European Union, passionate about broadening access
to biological medicines.
We care about global sustainability, speed to market, scientific rigour – in compliance with the highest quality requirements.
We care that our partners and our people enjoy working with us.
Polpharma Biologics
Polpharma Biologics is the trusted developer & manufacturer of biosimilars.
We are an international company, with integrated operations in the European Union, passionate about broadening access
to biological medicines.
We care about global sustainability, speed to market, scientific rigour – in compliance with the highest quality requirements.
We care that our partners and our people enjoy working with us.
Data Privacy Consent StatementINFORMATION ON PERSONAL DATA PROCESSINGBy sending the data contained in the recruitment notice and the application documents (in particular the application form, CV, cover letter and references), you consent to the processing of your personal data that you have given voluntarily, other than your forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications and career history, by Polpharma Biologics S. A. , with its registered office in Gdańsk at 3 Trzy Lipy Street, 80-172 Gdańsk, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000763945, waste database: 000120346, TIN: 9571112470, fully paid-up share capital: PLN 875, 000, 000. 00; (hereinafter: “Employer”)for the purpose of conducting the current recruitment process, i. e. assessing your qualifications, as well as the abilities and skills that are needed for working in the specific position for which you are applying – for 12 months.
In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation; hereinafter “GDPR”), we would like to inform you that:1. The Controller’s identity1. 1. Current recruitment processThe controller of your personal data which is being processed in the current recruitment process is the Employer. 1. 2. Future and other pending recruitment processes – database of candidatesAdditionally, you may agree to your data being saved in the candidate database used by the Polpharma Biologics Group companies for 36 months. In such a case, the Joint Controllers of your personal data will be the companies from the Polpharma Biologics Group, i. e. :Polpharma Biologics S. A. , with its registered office in Gdańsk at 3 Trzy Lipy Street, 80-172 Gdańsk, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000763945, waste database: 000120346, TIN: 9571112470, fully paid-up share capital: PLN 875, 000, 000. 00; Polpharma Biologics Warsaw Sp. z o. o. , with its registered office in Duchnice, at 4 Spółdzielcza Street, 05-850 Duchnice, postal district Ożarów Mazowiecki, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000498732, TIN: 1182096979, waste database number: 000476915, share capital: PLN 349, 835, 000. 00; Polpharma Biologics Utrecht B. V. . with its registered seat in Utrecht, The Netherlands, and its offices at Yalelaan 46, 3584 CM Utrecht, The Netherlands, registered with the Dutch Chamber of Commerce under registration no: 58858466; Polpharma Biologics Group B. V. , with its registered seat in Amsterdam, The Netherlands, and its offices at Herengracht 458, 1017 CA Amsterdam, The Netherlands, registered with the Dutch Chamber of Commerce under registration no: 76391825. (hereinafter also referred to as: the “Joint Controllers”);The companies will act as Joint Controllers with regard to keeping a common database of potential job candidates of the Company mentioned above. The database operated by them is managed by Polpharma Biologics S. A. If your application is considered within future or other pending active recruitment processes, the Joint Controller conducting the recruitment will act in this respect as a separate controller, processing data on the principles described in this clause. 2. Contact details2. 1. Personal data protectionYou can contact each of the controllers on all matters regarding personal data protection, in order to exercise your rights by sending an e-mail to: iod@polpharmabiologics.com2. 2. Other matters regarding recruitmentPlease contact us at career@polpharmabiologics.com in other recruitment matters. 3. Objectives of and grounds for processing personal data3. 1. Active recruitment process – including the current recruitment A. In the case of the processing of your personal data within an active (including current) recruitment process, your personal data will be processed to hold the recruitment process that is being conducted, i. e. to assess your qualifications, as well as the abilities and skills that are needed to work in the position for which you are applying, and in order to select a suitable person for that position – on the basis of:Article 6(1)(c) GDPR, i. e. the processing is necessary for fulfilling the controller’s legal obligation arising from the provisions of labour law (in particular Article 221 1 of the Labour Code) with regard to the following personal data: your forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications and career history; Article 6(1)(a) GDPR, i. e. on the basis of your voluntarily given consent with regard to the other personal data you have voluntarily provided in your application documents (in particular in your CV, your cover letter and your references);Article 6(1)(b) GDPR, i. e. processing is necessary to take steps at your request before entering into a contract (applies to recruitment for positions where the Employer enters into cooperation with the candidate on the basis of a legal relationship other than an employment relationship);Article 6(1)(f) GDPR, i. e. the processing is necessary for the purposes of the legitimate interests pursued by the controller, because of the possibility of contacting candidates even after the end of the recruitment process, if a person who qualified for the position does not take the job or the employment contract concluded with him/her is terminated within 12 months of the end of the recruitment process;Article 6(1)(f) GDPR, i. e. the processing is necessary for the purposes of the legitimate interests pursued by the controller – establishment, assertion or defence against possible claims between you and the data controller (with regard to all personal data you provided). B. Your provision of your personal data as specified in Article 221 § 1 of the Labour Code (i. e. forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications, employment history) arises from the statutory obligation to collect such data from people applying for employment, as specified in the Labour Code. It is necessary for you to be able to participate in the active recruitment process. The consequence of failing to provide this data is the inability to participate in the active (including the current) recruitment process. C. The provision of other personal data is voluntary and does not constitute a condition for participation in the active (including current) recruitment process. 3. 2. Processing personal data in the database of candidatesA. If you give your consent to the processing of your data in the database of candidates for the purposes of future or other pending recruitment processes, your personal data will be processed in order to keep a database of candidates for conducting future or other pending recruitment processes, i. e. assessing your qualifications as well as the abilities and skills that are needed to work in the position for which the recruitment is being conducted, and selecting a suitable person to work in that position – on the basis of:Article 6(1)(a) GDPR, i. e. your freely given consent – with respect to all personal data provided by you;B. The provision of your personal data and your consent to the processing of all your personal data in order to take part in future recruitment processes is voluntary, but it is a condition for the inclusion of your personal data in the above database which is kept for the purposes of future recruitment processes. 4. Categories of recipients of personal data4. 1. Your personal data may be disclosed to the following entities: employees and associates of the data controller, entities handling recruitment processes for it and on its behalf, IT service providers, as well as entities providing advisory and legal services and other entities from the Polpharma Biologics Group. 4. 2. Your personal data may be disclosed to entities and authorities that are authorised to process such data by law. 4. 3. The controller does not intend to transfer your personal data to countries outside the European Economic Area or to an international organisation. However, in certain situations related to personal data processing, data may be transferred outside the EEA. Personal data may only be transferred outside the EU or EEA either to countries that the European Commission has found to guarantee an adequate level of data protection or with appropriate safeguards, in particular through the use of EU Standard Contractual Clauses. In such cases, you may request a copy of these respective safeguards, in particular the EU Standard Contractual Clauses (if applicable), or the specification of where your data has been sent, by writing to: iod@polpharmabiologics.com 5. Period of personal data storage5. 1. Active recruitment process – including the current recruitmentA. Your personal data will be processed:for 12 months from the date of your application being considered for the particular recruitment process oruntil you raise an objection which is accepted (if the processing is based on the controller’s legitimate interest) or until you withdraw your consent (if the processing is based on the consent that has been given) whichever is the earlier. 5. 2. Processing personal data in the database of candidates A. Your personal data will be processed:for 36 months from the date of your consent to the processing of your personal data for future recruitment processesuntil you withdraw your consent whichever is the earlier. 6. Rights6. 1. You have the right to access your personal data and to demand its rectification, erasure or the restriction of its processing. 6. 2. You have the right of data portability, i. e. to receive your personal data, which you have provided to the personal data controller, in a structured, commonly used and machine-readable format. You may request the data controller to send this data to another controller. 6. 3. To the extent to which the processing of your personal data is based on your consent, you have the right to withdraw that consent. The withdrawal of consent shall be without prejudice to the lawfulness of the processing that was conducted on the basis of the consent before its withdrawal. 6. 4. You have the right to object to the processing of your personal data to the extent to which the basis for the processing of your personal data is a premise of the legally justified interest of the data controller. 6. 5. You may contact the data controller to exercise the above rights by sending an e-mail to: iod@polpharmabiologics.com6. 6. You have the right to file a complaint with the personal data protection supervisory authority (the president of the Personal Data Protection Office – Prezes Urzędu Ochrony Danych Osobowych) if you believe that the processing of your data is breaching the provisions of the law. 7. References 7. 1. If you provide information to us about other people, such as contact details for people who can provide references, you declare that these people have been informed of this and that they agree to the provision of their details. 7. 2. If you are the designated contac
Odpowiedz na ogłoszenieIn accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation; hereinafter “GDPR”), we would like to inform you that:1. The Controller’s identity1. 1. Current recruitment processThe controller of your personal data which is being processed in the current recruitment process is the Employer. 1. 2. Future and other pending recruitment processes – database of candidatesAdditionally, you may agree to your data being saved in the candidate database used by the Polpharma Biologics Group companies for 36 months. In such a case, the Joint Controllers of your personal data will be the companies from the Polpharma Biologics Group, i. e. :Polpharma Biologics S. A. , with its registered office in Gdańsk at 3 Trzy Lipy Street, 80-172 Gdańsk, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000763945, waste database: 000120346, TIN: 9571112470, fully paid-up share capital: PLN 875, 000, 000. 00; Polpharma Biologics Warsaw Sp. z o. o. , with its registered office in Duchnice, at 4 Spółdzielcza Street, 05-850 Duchnice, postal district Ożarów Mazowiecki, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000498732, TIN: 1182096979, waste database number: 000476915, share capital: PLN 349, 835, 000. 00; Polpharma Biologics Utrecht B. V. . with its registered seat in Utrecht, The Netherlands, and its offices at Yalelaan 46, 3584 CM Utrecht, The Netherlands, registered with the Dutch Chamber of Commerce under registration no: 58858466; Polpharma Biologics Group B. V. , with its registered seat in Amsterdam, The Netherlands, and its offices at Herengracht 458, 1017 CA Amsterdam, The Netherlands, registered with the Dutch Chamber of Commerce under registration no: 76391825. (hereinafter also referred to as: the “Joint Controllers”);The companies will act as Joint Controllers with regard to keeping a common database of potential job candidates of the Company mentioned above. The database operated by them is managed by Polpharma Biologics S. A. If your application is considered within future or other pending active recruitment processes, the Joint Controller conducting the recruitment will act in this respect as a separate controller, processing data on the principles described in this clause. 2. Contact details2. 1. Personal data protectionYou can contact each of the controllers on all matters regarding personal data protection, in order to exercise your rights by sending an e-mail to: iod@polpharmabiologics.com2. 2. Other matters regarding recruitmentPlease contact us at career@polpharmabiologics.com in other recruitment matters. 3. Objectives of and grounds for processing personal data3. 1. Active recruitment process – including the current recruitment A. In the case of the processing of your personal data within an active (including current) recruitment process, your personal data will be processed to hold the recruitment process that is being conducted, i. e. to assess your qualifications, as well as the abilities and skills that are needed to work in the position for which you are applying, and in order to select a suitable person for that position – on the basis of:Article 6(1)(c) GDPR, i. e. the processing is necessary for fulfilling the controller’s legal obligation arising from the provisions of labour law (in particular Article 221 1 of the Labour Code) with regard to the following personal data: your forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications and career history; Article 6(1)(a) GDPR, i. e. on the basis of your voluntarily given consent with regard to the other personal data you have voluntarily provided in your application documents (in particular in your CV, your cover letter and your references);Article 6(1)(b) GDPR, i. e. processing is necessary to take steps at your request before entering into a contract (applies to recruitment for positions where the Employer enters into cooperation with the candidate on the basis of a legal relationship other than an employment relationship);Article 6(1)(f) GDPR, i. e. the processing is necessary for the purposes of the legitimate interests pursued by the controller, because of the possibility of contacting candidates even after the end of the recruitment process, if a person who qualified for the position does not take the job or the employment contract concluded with him/her is terminated within 12 months of the end of the recruitment process;Article 6(1)(f) GDPR, i. e. the processing is necessary for the purposes of the legitimate interests pursued by the controller – establishment, assertion or defence against possible claims between you and the data controller (with regard to all personal data you provided). B. Your provision of your personal data as specified in Article 221 § 1 of the Labour Code (i. e. forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications, employment history) arises from the statutory obligation to collect such data from people applying for employment, as specified in the Labour Code. It is necessary for you to be able to participate in the active recruitment process. The consequence of failing to provide this data is the inability to participate in the active (including the current) recruitment process. C. The provision of other personal data is voluntary and does not constitute a condition for participation in the active (including current) recruitment process. 3. 2. Processing personal data in the database of candidatesA. If you give your consent to the processing of your data in the database of candidates for the purposes of future or other pending recruitment processes, your personal data will be processed in order to keep a database of candidates for conducting future or other pending recruitment processes, i. e. assessing your qualifications as well as the abilities and skills that are needed to work in the position for which the recruitment is being conducted, and selecting a suitable person to work in that position – on the basis of:Article 6(1)(a) GDPR, i. e. your freely given consent – with respect to all personal data provided by you;B. The provision of your personal data and your consent to the processing of all your personal data in order to take part in future recruitment processes is voluntary, but it is a condition for the inclusion of your personal data in the above database which is kept for the purposes of future recruitment processes. 4. Categories of recipients of personal data4. 1. Your personal data may be disclosed to the following entities: employees and associates of the data controller, entities handling recruitment processes for it and on its behalf, IT service providers, as well as entities providing advisory and legal services and other entities from the Polpharma Biologics Group. 4. 2. Your personal data may be disclosed to entities and authorities that are authorised to process such data by law. 4. 3. The controller does not intend to transfer your personal data to countries outside the European Economic Area or to an international organisation. However, in certain situations related to personal data processing, data may be transferred outside the EEA. Personal data may only be transferred outside the EU or EEA either to countries that the European Commission has found to guarantee an adequate level of data protection or with appropriate safeguards, in particular through the use of EU Standard Contractual Clauses. In such cases, you may request a copy of these respective safeguards, in particular the EU Standard Contractual Clauses (if applicable), or the specification of where your data has been sent, by writing to: iod@polpharmabiologics.com 5. Period of personal data storage5. 1. Active recruitment process – including the current recruitmentA. Your personal data will be processed:for 12 months from the date of your application being considered for the particular recruitment process oruntil you raise an objection which is accepted (if the processing is based on the controller’s legitimate interest) or until you withdraw your consent (if the processing is based on the consent that has been given) whichever is the earlier. 5. 2. Processing personal data in the database of candidates A. Your personal data will be processed:for 36 months from the date of your consent to the processing of your personal data for future recruitment processesuntil you withdraw your consent whichever is the earlier. 6. Rights6. 1. You have the right to access your personal data and to demand its rectification, erasure or the restriction of its processing. 6. 2. You have the right of data portability, i. e. to receive your personal data, which you have provided to the personal data controller, in a structured, commonly used and machine-readable format. You may request the data controller to send this data to another controller. 6. 3. To the extent to which the processing of your personal data is based on your consent, you have the right to withdraw that consent. The withdrawal of consent shall be without prejudice to the lawfulness of the processing that was conducted on the basis of the consent before its withdrawal. 6. 4. You have the right to object to the processing of your personal data to the extent to which the basis for the processing of your personal data is a premise of the legally justified interest of the data controller. 6. 5. You may contact the data controller to exercise the above rights by sending an e-mail to: iod@polpharmabiologics.com6. 6. You have the right to file a complaint with the personal data protection supervisory authority (the president of the Personal Data Protection Office – Prezes Urzędu Ochrony Danych Osobowych) if you believe that the processing of your data is breaching the provisions of the law. 7. References 7. 1. If you provide information to us about other people, such as contact details for people who can provide references, you declare that these people have been informed of this and that they agree to the provision of their details. 7. 2. If you are the designated contac
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