Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Head QA Operations
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
Head QA Operations
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Supports Life cycle management of a manufacturing facility up to and including GMP compliant commercial production
- Supports in all product/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 and APQRs
- Conducts activities related to the establishment, implementation and supervision on the required quality processes in product development, manufacturing, testing, storage and distribution.
- Leads and manages the QA Operations Team responsible for the release of commercial biopharmaceutical products for the market including certification according to Annex 16, Preparation of CoA and CoC
- Ensures a proper batch record review and review of all batch related documents, approval of Master Manufacturing Records and procedures for Drug Substance, Bulk Product and Drug Product manufacturing (e.g. sampling procedures), approval of Specifications for the product, Certificates/Statements of FDF Latex, PVC etc.
- Ensures that all processes and products in the unit have built-quality and meet all internal and external requirements.
- Participation in 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
- Ensures the correctness and data integrity of all regulatory relevant development and manufacturing data
- Ensuring cGMP and regulatory compliance of QA Operations leading to biological Drug Substance and Drug Product.
- Interacts with regulatory authorities
- Participates and represents Polpharma Biologics in internal and external audits
- Proper preparation and review of required GMP documents, assesses, gives guidance and approves the documentation prepared on-site or provided by external entities
What do we expect?
- 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, specifically in the ICH environment
- Knowledge of the technologies for producing drug substance and sterile pharmaceutical products
- Understanding analytical technologies related to the evaluation of (bio-)pharmaceutical products
- Knowledge of Quality Management Systems
- Fluent in English, Polish language will be an advantage
- Communicative, with strong interpersonal skills
- Able to work across organization and to make decision
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.