#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:
QA Operations Senior Specialist
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:
- Ensuring cGMP and regulatory compliance of operations leading to biological Drug Substance and Drug Product.
- Supporting 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 is achieved through qualification and validation based upon quality risk analysis, product quality assessments, and ongoing verification
- Supporting Life cycle management of a manufacturing facility up to and including GMP compliant market production
- Ensuring that all processes and products in the unit have built-quality and meet all internal and external requirements. Conducting activities related to the establishment, implementation and supervision on the required quality processes in product development, manufacturing, testing, storage and distribution.
- Batch record review and review of all batch related documents
- Participation in investigation on deviations and complaints, OOS/OOT, recalls and escalations; supporting change control requests, assuring GMP and regulatory compliance in the requests. Participation in risk assessments
- Supporting all 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);
- Supporting preparation of APQRs
- Proper preparation and review of required GMP documents, assisting in the coordination and preparation of Polpharma Biologics for the inspections and controls. Supervising preparation of PB areas for a variety of inspections and audits. Participating in internal and external audits.
- Supporting the establishment of Quality Management System documentation in accordance with the requirements of Polpharma Biologics and the HA requirements of the areas where the products are marketed
- Ensuring the correctness and data integrity of all regulatory relevant development and manufacturing data
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 the evaluation of biopharmaceutical products, knowledge in technologies producing sterile pharmaceutical products
- Understanding the issues and needs of qualification and validation in biopharmaceutical manufacturing
- Knowledge in Quality Management systems including quality requirements in clinical trials and Pharmacovigilance Experienced in Biotechnology manufacturing or commercial production
- Fluent English
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
