Oferta pracy

Audit and Inspection Head

Polpharma Biologics

  • Gdańsk

    Gdańsk, Pomeranian
  • offer expired a month ago
  • contract of employment
  • full-time
  • team manager
  • hybrid work

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.                 

Our requirements

  • 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.

What we offer

  • Competitive salary;

  • Private healthcare;

  • Life insurance;

  • Pension plan above national standards;

  • Relocation package;

  • Additional free day;

  • and more..

  • Benefits

  • private medical care

  • sharing the costs of professional training & courses

  • life insurance

  • remote work opportunities

  • flexible working time

  • extra social benefits

  • pre-paid cards

  • employee referral program

  • charity initiatives

  • extra leave

Polpharma Biologics

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!

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