QC Stability Expert
Place of work: Gdańsk
ROLE PROFILE:
- Main responsible person and expert for Stability Studies at Polpharma Biologis
- Maintaining a stability study concept and procedure according regulations, e.g. ICH guidelines
- Preparation of all documents related to stability studies of biopharmaceuticals, e.g. study plans and reports
- Supervises assigned Stability testing staff members and their daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems
- Stability sample management, including logging in of samples, storing samples in environment chambers, coordinate periodic sample pull for testing and distribution of samples amongst the Quality Control Laboratory network, disposing samples when stability testing is completed
- Maintaining all original documentation related to the Stability Program, including creating study folders, generating test forms for monthly sample pull, filing all original test forms and any associated documentation in study folders, transfer filings of all completed study folders in accordance with the company’s document retention SOP
- Initiating new stability studies
- Perform trend analysis of results, identification of OOS/OOT test results and subsequent investigation
- 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
REQUIREMENTS:
- 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
WE OFFER:
- Employment contract with opportunity to help shape the success of a leading private pharmaceutical company, working in a cutting edge biotech laboratory and great opportunity for professional development and participation in training programs
- Competitive salary, performance-related bonus and attractive fringe benefits
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.