#PolpharmaBiologics 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 medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
WE ARE LOOKING FOR:
Head of QA Compliance
Gdańsk Science & Technology Park, Trzy Lipy 3
WHAT MAKES US SPECIAL
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
You will take care of:
- Developing, implementing and supervising all Quality Management Systems
- Developing and maintaining the GMP relevant system documents. This includes all quality systems as Deviation Management, Change Control, CAPA Management, Supplier Management, Document Management and Training, Qualification and Validation Procedures, etc
- Monitoring Implementation of Quality Systems with respective KPIs
- Reviewing, verifying and approving GMP documents and ensuring compliance of the QMS with GMP, EU, FDA and local requirements
- Making sure that all actions in deviations and complaints are properly conducted and closed (including root cause identification) in accordance with all relevant regulations and laws. Making sure that all corrective and preventive actions are properly defined, planned, distributed and finalized in expected time
- Overseeing change control process, making sure that proposed changes are in compliance with cGMP
- Overseeing review and approval of suppliers, reviews technical/quality agreements
- Ensuring review of all documentation generated from the manufacturing and quality control area including environmental monitoring, cleaning records, equipment parameters/log books and microbiology exception reports
- Ensuring preparation of the Unit for pharmaceutical inspections and audits by national and foreign authorities. Representing the company during regulatory inspections. Interacting with regulatory authorities
- Overseeing activities of and managing the Quality Compliance Team
If you have:
- Higher education in biologics, chemistry, pharmacy, biotechnology or related, supported by min. 5 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.
- Excellent knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceutical drug substance and sterile products
- Knowledge of Quality Management Systems, with specific understanding in managing deviations, investigations and corrective/preventing actions
- Fluent knowledge of English both, written and spoken.
- Ability to make decisions, to work as a team and lead the Quality Compliance team
Join our Team!
We offer
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com