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QC Compliance Senior Specialist

Duchnice, 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!

Our Quality Control department carries out activities related to process monitoring and cooperation with external partners to ensure the safety and efficacy of our products.

The QC Compliance Senior Specialist position does not involve direct laboratory work but focuses on managing quality processes and supporting the team in compliance and documentation.

We are looking for a candidate to join the team and support quality objectives.

 

Your Responsibilities:

 

  • Processing deviations and Corrective and Preventive Actions (CAPA), control of changes and their effectiveness

  • Analyzing trends in product stability results and other quality Key Performance Indicators (KPIs)

  • Cooperation with suppliers of reagents and services, including contract testing laboratories

  • Managing samples and Quality Control documentation

  • Participation in internal and external audits and inspection readiness preparations

  • Working with IT systems such as TrackWise (quality management system), SAP (Enterprise Resource Planning system), LIMS (Laboratory Information Management System), and EMS Flexdat

  • Supporting training processes and building quality culture within the department

 

Our Expectations:

 

  • Higher education, preferably in biotechnology, pharmacy, or related life sciences

  • At least 5 years of experience in the pharmaceutical or biotechnology industry

  • Very good command of English, both spoken and written

  • Knowledge of Good Manufacturing Practice (GMP) requirements

  • Proficiency in Microsoft Office, especially Excel

  • Strong communication skills and ability to collaborate with internal teams and external partners

 

 

We Offer:

 

  • 24 days of home office per year

  • Flexible working hours: single shift Monday to Friday, 7:00-15:00 or 8:00-16:00

  • Attractive benefits package: medical care, lunch card, subsidy for English language learning, subsidy for professional development (studies/courses/trainings), wide range of internal trainings, holiday allowance, massages

  • Subsidy for your holiday

  • Additional day off

  • Opportunities for professional development and internal promotion

  • Free employee shuttle bus

  • Stable employment in a fast-growing biotechnology company
Why you should work with us

Contact us
career@polpharmabiologics.com

Apply now »