Quality Management System 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!
As a Quality Compliance Expert, you will participate in the supervision of compliance with the principles of GMP in Polpharma Biologics departments. You will play key role in creation, continuous improvement, and maintenance of Quality Management System in cooperation with cross functional teams.
Your responsibilities include, but are not limited to:
- Implementation, maintenance and monitoring of the Quality Management System processes at Site, including but not limited to Change Control, CAPA, Deviation Management, Risk Management, Quality Management System Review, Internal Audit, Complaints, Quality Management Review, Documentation Management, Training Management.
- Training employees on the procedures of the Quality Management System.
- Conducting and approving investigations.
- Conducting Audits.
- Participation in preparation and handling of audits and inspections at Polpharma Biologics.
If you have:
- Higher education with a specialization in the fields: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related.
- At least 10 years of experience in a GMP environment.
- At least 5 years of experience in Quality, preferably experience in QA departments.
- Experience-based knowledge in the field of change control processing, CAPA, deviations, risk management, documentation management, complaints, quality review.
- Knowledge of Pharmaceutical Law, GMP requirements and regulations regarding medicinal products, investigational medicinal products and active substances.
- Ability to think strategically and analytically. Organizational skills, decision-making skills.
- Fluent use of English in speech and writing.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Private pension plan.
- Relocation package.
- And more…
