QA Process and Cleaning Validation Expert
Gdańsk
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
- Serving as Subject Mater expert for Cleaning and Process Validation according to cGMP and FDA requirements;
- Review and approve validation documentation and provide guidance to site staff on cGxP requirements for cleaning and process validation;
- Performing and approving the GxP risk and impact assessments ;
- Approving Deviations, CAPAs and Change controls related to Process and Cleaning Validation;
- Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11 and internal procedures;
- Collaborate with Production, MS&T, Engineering and other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables.
If you have
- Higher directional education (Chemistry, Biotechnology or technical related fields);
- Possess working knowledge of global GxP regulations (GMP, 21 CFR Part 11, Data Integrity);
- Knowledge and understanding of latest industry data integrity trends, lifecycle management for cleaning and process validation;
- Minimum 5+ years of experience in pharmaceutical industry with strong knowledge about cleaning and process validation;
- Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure;
- Strong change control and root cause analysis experience;
- Experience in creation/maintenance & implementation of SOPs;
- Must be well-organized and a team player;
- Must be detail oriented, with strong analytical and problem-solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems;
- Fluent English;
- Flexibility, communication skills, teamwork spirit.
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.