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.
QC Stability Expert
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
QC Stability Expert
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Main responsible person for Documentation and Standards in QC Polpharma Biologis
- Ensures that all data in the lab area are accurate and integer on paper and electric records
- Ensures that all QC documents (plans, reports, results, method, specifications, etc.) are well managed, consistent and compliant.
- Reviews CAPAs, deviations, change controls, OOSs, risk analysis and ensures all records are closed in a timely manner and according to procedures.
- Assists owners in CAPA, root cause analysis, deviation investigation, OOS investigations, risk analysis
- Ensures that the most updated regulation (USP…) is implemented
- Pull and analyzes metrics to measure effectiveness and makes recommendations
- Interfaces auditors during inspections, participates to QC internal audit
- Ensures that all corrective actions from internal and external audits are effective and verified
- Follows, interprets and develops written Policies and Standard Operating Procedures
- Monitors internal audit non-conformances, perform trend analyses, and present findings
- Participates in process improvement activities to continuously improve effectiveness
- Reviews completed quality records to ensure completeness and adequacy.
- Participation or lead in documenting, investigating, troubleshooting and preventing recurrence of deviation
- Represents Polpharma with clients and prospective clients
- Participation and representation of Polpharma Biologics in internal/external audits
What do we expect?
- Higher education in biologics, chemistry, pharmacy, biotechnology or related, supported by min. 2 years of work experience in the pharmaceutical industry,
- Excellent knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceutical drug substance and sterile products and stability studies
- Knowledge of physicochemical, biological and microbiological methods
- minimum 2 years of laboratory experience (in regulated environment).
- Fluent knowledge of spoken and written English
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.