Quality Compliance Senior Specialist
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!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Role:
Quality Compliance Senior Specialist assists Suppliers Qualification Manager in developing, implementing and supervising the operation of the Quality Management System. Support in the preparation of the Unit for pharmaceutical inspection and audits led by national and foreign authorities. Ensures proper course of action during deviations investigations, corrective and preventive actions implementation and change control management. Interacts with authorities and third parties.
Your responsibilities:
- Preparation, revision and approval of quality documentation according to law requirements, GMP requirements and QAA requirements.
- Cooperation with other Polpharma Biologics S.A. departments and external parties during preparation of documentation connected with dossier preparation or changes in regulatory dossier.
- Cooperation with other Polpharma Biologics S.A. departments and external parties in scope of Supplier Qualification Unit duties.
- Participation 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 S.A.
- Review and approval of reported deviations, and complaints in accordance with the procedures in force and in accordance with legal requirements.
- Participation in risk analysis, ensuring compliance with GMP regulations internal procedures of Polpharma Biologics S.A.
- Participation in proceeding the initiated corrective and preventive actions in accordance with the procedures in force.
- Active participation and substantive assistance in solving quality problems and preventing their occurrence.
- Supporting suppliers qualifications process management.
- Participating in internal and external audits.
- Supporting External Audits Management.
- Preparation of quality contracts with service providers and materials.
- Participation in the complaint process of suppliers of materials / services.
- Performing duties in accordance with current GMP regulations and other pharmaceutical requirements.
- Performing duties delegated by Manager
- Ensures timely preparation of data required to prepare monthly / quarterly / 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.
- Informing Manager about quality issues, negative trends, audit observations, and especially when they may affect patient safety, quality and effectiveness of medicinal products."
- Project management in terms of responsibilities.
- Participate in the preparation for audits and inspections in Polpharma Biologics S.A
- Conducting internal training in scope of quality assurance and GxP for company employees at all levels of management.
- Development, revision, update, archiving of GMP documentation and QA Section. documentation (paper and electronic) in PB.
If you have:
- Higher education in biologics, chemistry, pharmacy, biotechnology or related.
- 5 years of work experience in the pharmaceutical industry, including two years in the Quality Assurance and Quality Control areas.
- Knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH environment.
- Knowledge of Quality Management Systems.
- Fluent knowledge of English both, written and spoken. Knowledge of Polish both, written and spoken.
- Ability to work with MS Office.
- Ability to make decisions. Ability to work as a team member and a team lead.
- Communication skills
- Ability to solve problems.
- Ability to perform complex tasks.