#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:
Quality Compliance Senior Specialist
Gdansk 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
In this position you will take part in preparations for audits and inspections. You will work with Quality documentation and you will be responsible for reporting on quality standards, deviations and CAPAs.
You’ll also take care of:
- Improvement activities to continuously improve effectiveness and compliance in Quality Control
- Reviewing quality records of Quality Control to ensure completeness and adequacy
- Implementing new GMP regulations and compile or update SOPs defining these regulations
- Investigations related to deviations, corrective and preventive actions implementation and change control management
- Preparation of Polpharma Biologics for pharmaceutical inspections and audits conducted by national and international regulatory bodies
- Performing regular compliance checks in Quality Control
- Ensuring that all corrective actions after internal and external audits are effective and verified
- Monitoring of internal audit non-conformances, performing trend analyses, and monitoring of current findings
- Contact and cooperation with domestic and foreign regulatory authorities
If you have:
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or similar)
- Min. 5 years of working experience in pharmaceutical industry, including min. 2 years of laboratory experience (in GLP/GMP environment)
- Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, biopharmaceuticals specifically
- Understanding of analytical technologies related to the evaluation of pharmaceutical products
- Knowledge of Quality Management Systems, with specific understanding in managing deviations, investigations and corrective/preventing actions as a main tool in the areas
- Decision making ability
- Teamwork ability
- Ability to interpret and apply domestic and international regulations
- Very good command of English, written and spoken
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
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com