Audit and Inspection Head
Gdańsk

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

Audit and Inspection Head (AIH)  is responsible for developing, implementing and supervising the operation of the Quality Management System. They play instrumental role in the preparation of the Unit for pharmaceutical inspections and audits led by foreign and national authorities, as well as they ensure proper course of action during documentation, trainings, internal audits, deviations investigations, corrective and preventive actions implementation and change control management. AIH will report directly to the Quality Director.

Your responsibilities

  • Preparation, revision and approval of quality documentation according to law requirements, GMP requirements and QAA requirements;
  • Participation in risk analysis process, ensuring that it is in compliance with GMP regulations and that change control management is in compliance with internal procedures of Polpharma Biologics;
  • Effective cooperation with other Polpharma Biologics S.A. departments in scope of Departments duties;
  • Cooperation with other Polpharma Biologics S.A. departments during preparing documentation connected with changes in regulatory dossier;
  • Reviewing and approving reported deviations, OOX and complaints in accordance with the procedures in force, according to legal requirements;
  • Active participation in proceeding the initiated corrective and preventive actions in accordance with the procedures in force;
  • Taking part in change control process, ensuring that proposed changes are in compliance with GMP regulations and that change control management is in compliance with internal procedures of Polpharma Biologics;
  • Ensuring timely preparation of data required to prepare monthly, quarterly and annual quality system reviews;
  • Participation in organization, implementation, systematic assessment of effectiveness and improvement of the quality system in accordance with current legal requirements, including GxP requirements, in the scope covered by the authorization for the production of medicinal products and the authorization to imported medicinal products;
  • Participating in processes related to the suspension and/or withdrawal of the medicinal product and the investigational medicinal product from the market;
  • Participation in the preparation for audits and inspections (FDA, EMA) in Polpharma Biologics;
  • Conducting internal trainings in scope of quality assurance and GxP for company employees at all levels of management;
  • Approval of Quality Agreement;
  • APQR Management;
  • Development, revision, update, distribution and archiving of GMP documentation and QA Section documentation (paper and electronic) in Polpharma Biologics S.A.;
  • Complaint Management for Medicinal Product and IMP;                  
  • Tracking, interpretation, implementation and compliance with current GMP and pharmaceutical law requirements in the field of manufacturing, importing medicinal products and investigational medicinal products;
  • Cooperation in the preparation of the Quality Plan and establishing quality indicators;
  • Ensuring timely preparation of data, within the responsibility of the subordinate Department, required to develop annual quality reviews of medicinal products and investigational medicinal products;
  • Representing the company during regulatory inspections and external audits.                 

If you have

  • Minimum of 8 years of work experience in the pharmaceutical industry, including two years in the evaluation of pharmaceutical products in the area of control or quality assurance;
  • Master’s degree in science/health-related field (such as: biology, biochemistry, chemistry, pharmacy, biotechnology);
  • Very good knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH environment;
  • Experience with internal and external Audits Management, as well as approval of Deviation, Change Control and CAPA process;
  • Extensive experience with preparation and leading and/or participation in FDA, EMA inspections;
  • Excellent understanding of Quality Management Systems;
  • Ability to make well-reasoned decisions, problem solving mindset;
  • Ability to work as a team member and a team lead;
  • Very good communication skills, including senior management;
  • Working knowledge of MS Office package.

We offer

  • Competitive salary;
  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more..
Join our Team!

Why you should work with us

Contact us
[email protected]

INFORMATION ON PERSONAL DATA PROCESSING

 

By 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 identity

 

1.1. Current recruitment process

 

The 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 candidates


Additionally, 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 details

2.1. Personal data protection

You 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: [email protected]


2.2. Other matters regarding recruitment


Please contact us at [email protected] in other recruitment matters.


3. Objectives of and grounds for processing personal data


3.1. 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 candidates


A. 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 data

4.1. 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: [email protected]

 

5. Period of personal data storage

5.1. Active recruitment process – including the current recruitment

1. Your personal data will be processed:

  • for 12 months from the date of your application being considered for the particular recruitment process or
  • until 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


1. 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 processes
  • until you withdraw your consent 

whichever is the earlier.


6. Rights


6.1.
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: [email protected]


6.6.
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 contact person for providing references for the job candidate, your personal data, such as contact details will be processed for the purpose of obtaining information on the candidate’s qualifications under Article 6(1)(f), i.e. the legitimate interest of the controller, on the terms specified in this document (with the exception of the provisions of clause 3). We may also process information related to your credentials – such as the place of your employment, information about your professional relationship with / knowledge of the candidate and your opinions about him/her. We may obtain this information directly from you, from the candidate or from publicly available sources.  If we obtain data directly from you, the provision of such data is voluntary. 



8. Automated decision-making


8.1
No decisions will be made with respect to you in an automated manner, including as a result of profiling.