Quality Control Microbiology Coordinator
Miejsce pracy: Gdańsk
RESPONSIBILITIES:
- Establishing and operation of Quality Control Microbiology laboratory
- Introduction and upkeep of GMP system in the laboratory
- Managing and coordination of the activities of reporting team
- Performing all duties according to current applicable GMP rules and other pharmaceutical regulations
- Preparation and review of microbial method validation, qualification of equipment and microbial method transfer
- Preparation and review of protocols, reports, procedures and all required documents
- Sampling and testing of: clean utilities, raw materials, product - IPC, final product
- Preparation of reagents and reagent management
- Participation in internal and external audits
REQUIREMENTS:
- Higher education in microbiology, biology, biotechnology, chemistry, pharmacy or related disciplines
- Minimum 5 years of work experience at similar position
- Theoretical and practical knowledge of methods transfer, environmental, water and compressed gases monitoring, microbial identification, endotoxin testing, microbial testing of raw materials, IPC and final product, QC of microbial media
- Advanced knowledge of the GLP and GDP regulations
- Experience in participation in internal and external audits
- Proficiency in English, both written and spoken
- MS Office knowledge
- Ability of independent problem solving, analytic thinking, good organizational skills and leadership skills
- Ability to prioritize and meet demanding deadlines and timescales in a fast moving environment
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.