Validation Manager
Duchnice
(replacement employment contract)
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!
Your responsibilities:
- Implementation of the reclassification plans for the Company’s critical equipment and systems.
- Ensuring the implementation of the department’s plans.
- Supervision over the course of validation processes.
- Ongoing provision of reports and documentation to the supervisor and/or the appropriate persons to evaluate the process.
- Preparation of the Department for internal and external audits. Participation in all audits in the reporting area.
- Cooperating with all groups, both in the Branch and in the Polpharma Biologics Group.
If you have:
- University degree.
- Knowledge of cGMP and FDA regulations.
- Minimum 5 years of experience in conducting qualification activities (IQ, OQ i PQ).
- Experience in document validation in accordance with GMP regulations.
- Knowledge of Annex 11, Annex 15 and 21 CFR part 11.
- Knowledge of English (B2 minimum).
- People management experience.
- Communication skills, openness to new tasks.
- Excellent organizational and problem-solving skills.
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.