#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!
Quality Compliance Senior Specialist
Gdańsk Science & Technology Park, Trzy Lipy 3
For our Quality Compliance Department we are currently looking for a Senior Specialist. On this position you will participate in improvement activities to continuously improve effectiveness and compliance in all GMP areas. It is an exciting opportunity to join the Compliance Department within a dynamic, fast moving environment and get experience in biotech industry.
- Implementing new GMP regulations and compiling or updating SOPs defining these regulations
- Supporting deviations investigations, corrective and preventive actions
- Implementation and change control management
- Assisting in preparation of Polpharma Biologics for pharmaceutical inspections and audits conducted by national and international regulatory bodies
- Performing regular compliance checks in GMP areas
- Ensuring that all corrective actions from internal and external audits are effective and verified
- Monitoring internal audit non-conformances, perform trend analyses, and present findings
- Contact and cooperation with domestic and foreign regulatory bodies
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or similar)
- 3 years of working experience in pharmaceutical industry
- Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically for biopharmaceuticals
- Knowledge of Quality Management Systems, with specific understanding in managing deviations, investigations and corrective/preventing actions as general tool in the areas
- Ability to interpret and apply domestic and international regulations
- Ability to make decisions
- Team spirit
- Fluent Polish, written and spoken
- Fluent English, written and spoken