QA TR&D Assistant
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 role
Participate in Quality Management System (QMS) building in Technical and Development Department (TR&D) in Gdańsk site. Revision and archiving of scientific projects data and equipment maintenance documentation. Maintaining of Quality registers and training system for TR&D. Support in area preparation for inspections.
Your responsibilities
- Support in implementation and monitoring of the Quality System in the TR&D Department
- Support in preparation of the TR&D area for inspections and audits
- Verification of documentation in TR&D areas in terms of compliance with the applicable internal procedures and current regulations
- Contact with the TR&D Department of Polpharma Biologics to adapt the procedures and quality requirements to the standards of Polpharma Biologics
- Revision and approval of the documentation related to technical and computerized systems in TR&D
- Archiving of documentation
- Maintaining registers of documentation, equipment calibration and maintenance activities
- Working with electronical documentation systems
- Preparation of presentations associated with Quality System in TR&D
If you have
- Master’s or Bachelor degree in a relevant field (pharmacy, biology, biotechnology, biochemistry, chemistry)
- Good knowledge of spoken and written English
- Knowledge of MS Office
- Good organization of work and time
- Ability to cooperate with others to solve problems
- Motivation to work and development