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.
Quality Control Physicochemical Coordinator
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
Quality Control Physicochemical Coordinator
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Manage QC team, motivate employees towards achieving the objectives set
- Prepare, review and approve procedures, instructions and other QC's documents
- Ensure performance of all necessary physicochemical tests and evaluation of related records
- Timely release or reject tested intermediates, product in bulk and final product. Timely and reliable performance of analysis
- Ensure performance of all appropriate method transfers and validations
- Ensure maintenance and qualification of premises and equipment in the department
- Ensure providing introductory and tailored-to-the-needs employee trainings
- Participate in internal and external audits
- Perform all duties with respect to current GMP requirements and other pharmaceutical regulations
- Approve and monitor contract analysts and laboratories
- Manage out-of-spec results, deviations and inconsistencies observed in manufacturing process and tests conducted by team members
- Plan both own and subordinate employees’ work and progress reporting
- Manage and supervise stability studies
What do we expect?
- Higher education with specialization in the fields like: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related
- Practical and theoretical knowledge regarding transfer and validation of analytical methods, stability studies, liquid chromatography related to working with biological drugs (such as: peptide mapping, size exclusion, ion exchange), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopoeial methods used for release of raw materials, intermediates and final drug product
- 5 years of experience in regulated laboratory environment (biotechnological lab preferred). Very good knowledge of GMP and GDP rules
- Very good knowledge of GMP and GDP rules and ability to implement and supervise compliance with these rules within a laboratory environment
- Communicative knowledge of English
- Good knowledge of MS Office
- Very good ability to organise the work of a team and one’s own duties, ability to work under time pressure
- very good cooperation with others in order to solve the problems
- Keeping timelines, ability to prioritize tasks
- Analytical thinking
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.