Quality Operations Senior Specialist

Gdańsk, PL

Boost your career with us
Polpharma Biologics is a biopharmaceutical company with state-of-the-art facilities across Europe. Operating across international centers of excellence specialized in cell line development, product and process development, clinical manufacturing, commercial scale production and regulatory affairs, allows us to work and partner on our in-house biosimilar pipeline and at the same time provide top-quality contract development and manufacturing services to the industry.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Boost your career with us

Polpharma Biologics is a biopharmaceutical company with state-of-the-art facilities across Europe. Operating across international centers of excellence specialized in cell line development, product and process development, clinical manufacturing, commercial scale production and regulatory affairs, allows us to work and partner on our in-house biosimilar pipeline and at the same time provide top-quality contract development and manufacturing services to the industry.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

If you're passionate about maintaining the highest GMP standards and want to contribute to the development of biosimilar medicines, we have a role for you.

 

Your responsibilities include, but are not limited to:

  • Ensuring proper preparation, assessment, and approval of GMP and quality documentation.
  • Participating in pharmaceutical inspections and audits conducted by national and international regulatory authorities.
  • Developing, implementing, and maintaining the Quality Management System in accordance with internal and external regulations.
  • Reviewing batch records and certifying manufacturing steps for drug substances, bulk products, and investigational medicinal products (IMPs).
  • Making independent decisions regarding product release or rejection in the capacity of an Authorized Person.
  • Supporting change control, risk assessment, and deviation management processes.
  • Conducting and/or participating in internal and external audits.
  • Verifying production processes for compliance with GMP through regular shop floor presence.
  • Delivering GMP training and supporting continuous improvement initiatives.

 

If you have:

  • Minimum 5 years of experience in the pharmaceutical industry, including at least 2 years in product evaluation within QA or QC.
  • Higher education in biology, chemistry, pharmacy, biotechnology, or related field.

  • Strong knowledge of GMP requirements and pharmaceutical law, especially in the ICH environment.
  • Proven working knowledge of the QMS. 
  • Proficiency in English, both spoken and written.
  • Strong decision-making and teamwork skills.
  • Familiarity with quality systems and manufacturing technologies for pharmaceuticals.

 

What we offer:

  • Competitive salary.
  • Private healthcare.
  • Life insurance.
  • Pension plan above national standards.
  • Additional free day.
  • and more..
Why you should work with us