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