Quality Operations Specialist
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!

Your role

In this role you will participate in the development, implementation, and supervision of the Quality Management System in the Quality Operations Department. You will also take part in preparations of Polpharma Biologics S.A. for pharmaceutical inspections and audits carried out by domestic and foreign regulatory authorities. You will be tasked with ensuring the correct conduct of processes for which the Quality Operations Department is responsible, including the batch documentation assessment process.

Your responsibilities

  • Proper preparation and reviewing of GMP documents, including issuance and review of Batch Records
  • Assessment of the documentation prepared by Polpharma Biologics S.A. or provided by external entities
  • Developing and updating the system documentation
  • Participation in inspections of pharmaceutical authorities and customer audits, to the extent specified by the supervisor
  • Participation in internal audits
  • Participation in the processes of change control, risk analysis and deviation, including investigations
  • Fulfillment of obligations under the current GMP regulation and other pharmaceutical guidelines
  • Fulfilling tasks assigned by the supervisor
  • Participation in the initiated corrective and preventive actions in accordance with the applicable procedures
  • Verification of production processes for compliance with GMP requirements through regular visits in the production area
  • Conducting trainings for new employees

If you have

  • 2-3 years of experience in a similar position
  • University degree in biology, chemistry, pharmacy, biotechnology or related
  • Basic knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals
  • Knowledge of Quality Management Systems
  • Fluent knowledge of Polish both, written and spoken
  • Fluent knowledge of English both, written and spoken
  • Ability to work with MS Office
  • Ability to work in a team
  • Basic knowledge of the technology of manufacturing pharmaceutical products and analytical methods related to their assessment

We offer

  • Private healthcare
  • Life insurance
  • Pension plan above national standards
  • Relocation package
  • International work environment
  • Additional free day
  • and more…
Join our Team!

Why you should work with us