Quality Control Support Team Senior Specialist
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Role:
At this position you will join our Team of specialists dedicated to support of Quality Control activities at Polpharma Biologics. Your main tasks will be to take care of Quality related documentation and its proper processing within our Quality Management Systems.
Your responsibilities
- Developing new and updating existing documentation (instructions, procedures, risk assessment)
- Quality oversight over QMS processes (incl. change control, deviation, CAPA and risk management)
- Tracking and monitoring of Quality KPI’s
- Participation in internal and external audits and implementation of post-audit recommendations,
- Documentation management (Distribution of quality system documents in QC),
- Supervision and distribution of reagents, reference standards
- Participation in the implementation of laboratory systems (LIMS, SAP)
- Providing trainings for Quality Control personnel
If you have
- University degree (Biology, Chemistry, Biotechnology or related)
- 5 years of working experience in the pharmaceutical industry, incl. 3 years in Quality Control and/or Quality Assurance of pharmaceutical products
- Experience and knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry
- Organizational skills, highly developed communication, and presentation skills
- Fluent in written and spoken English
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.