#PolpharmaBiologics 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 medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
WE ARE LOOKING FOR:
Senior Qualification Specialist
Gdańsk Science & Technology Park, Trzy Lipy 3
WHAT MAKES US SPECIAL
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
You will take care of:
- Preparation of qualification documentation: qualification plans, protocols and reports
- Conducting the qualification tests related to Production/Process Equipment or Quality Control Equipment
- Initiating and leading the Risk Assessments
- Monitoring and supervision of system documentation related to qualification activities
- Conducting trainings on procedures for qualifying activities
- Conducting activities in accordance with the applicable cGMP, FDA and internal procedures
- Overseeing the qualification status of equipment and production installations
- Initiating corrective actions resulting from deviations identified during qualification activities
- Verification of the qualification documentation and comparison of the obtained results with the acceptance criterion
- Revising validation and qualification documentation of the Direct Impact Systems
If you have:
- Higher directional education (biotechnology, biology, pharmacy or technical related fields)
- Knowledge of the cGMP and FDA regulations
- Experience with production/ process or quality control equipment
- Experience in developing qualification documentation in accordance with GDP and GMP principles
- Experience in conducting qualifying activities on Risk Assessments, DQ, IQ, OQ and PQ
- Ability to recognize and solve problems independently, good organization skills, ability to work efficiently under time pressure
- Fluent English
- Flexibility, communication skills, teamwork spirit
Join our Team!
We offer
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
