Quality Control Compliance Senior Specialist

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 new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us! www.polpharmabiologics.com

We are looking for:

Quality Control Compliance Senior Specialist


You will take care of:

  • Participating in 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.
  • 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 quality control.
  • Ensuring that all corrective actions from internal and external audits are effective and verified. Monitors internal audit non-conformances, perform trend analyses, and present findings.
  • Contact and cooperation with domestic and foreign regulatory bodies.

If you have:

  • Higher education in biologics, chemistry, pharmacy, biotechnology or related,  supported by min. 5 years of work experience in the pharmaceutical industry, including min. two years of laboratory experience (in regulated environment).
  • Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically for biopharmaceuticals.
  • Understanding 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 general tool in the areas
  • Ability to make decisions. Ability to work as a team.
  • Ability to interpret and apply domestic and international regulations.
  • Fluent knowledge of Polish both, written and spoken. Fluent knowledge of English both, written and spoken

Join our Team!

We offer:

  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more


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Polpharma Biologics S.A.

Polpharma Biologics S.A.

Quality Control Compliance Senior Specialist

Miejsce pracy: Polska, Pomorskie, Gdańsk
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Ważna jeszcze 0 dni (do 2019-09-02)

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