#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 Operations
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 Quality Management System in area of direct manufacturing operations, production process related deviations, batch release, complaints' management, product withdrawals, and data integrity
- Ensuring proper implementation and maintenance of Standard Operating Procedures related to the area of responsibility
- Support of the whole Life-cycle of a product and process related activities e.g. process transfers, process characterization, process validation and continuous process verification (including e.g. stability studies, hold time studies, E&L; approval of protocols and reports; up to and including GMP compliant market production
- Participation in the investigation on deviations and complaints, OOS/OOT, recalls and escalations; support change control requests, assure GMP and regulatory compliance in the requests, Participation in risk assessments
- Ensuring that all processes and products in the unit have built-quality and meet all internal and external requirements.
- Making sure that all aspects of the handling, manufacturing of biopharmaceutical products at the site comply with the requirements meet all relevant cGMP regulatory and legislative requirements. Ensuring that a high quality of products (Drug Substance and Drug Product) is achieved through development, transfer and validation based upon quality risk analysis, product quality assessments, and ongoing verification
- Preparing Quality Operations Unit for pharmaceutical inspections and audits led by national and foreign authorities. Participating and representing Polpharma Biologics in internal and external audits
- Proper preparation and review of required GMP documents, providing support in the preparation for inspections. Participation in internal and external audits
- Participation in project/product team meetings representing QA
- Fulfilment of legal requirements according to which in the company manufacturing IMPs function of Qualified Person must be established
- Batch disposition (release or rejection of a batch of investigational medicinal product) in the range defined by current pharmaceutical law
- Supporting preparation of APQRs
- Leading and managing Quality Operations 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 and pharmaceutical laws and regulations related to pharmaceuticals, especially in the ICH environment
- Understanding of analytical technologies related to biopharmaceutical products, knowledge in technologies of Drug Substance and Drug Product production
- Understanding the needs of biopharmaceutical manufacturing
- Fluent knowledge of English both, written and spoken
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