QA Systems Senior Specialist (maternity cover)

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!

As a Senior Quality System Specialist, you’ll play a key role in ensuring the continuous improvement and compliance of our Quality Management System. You will support core quality processes and digital systems that enable us to deliver life-changing therapies — safely and effectively.

 

Your responsibilities include, but are not limited to:

  • Act as a deputy of the Quality Compliance and Management Review Manager.
  • Drive implementation and enhancement of the Quality System.
  • Manage and oversee Deviation, (s)CAPA, Change Control, Recall, Complaints & Escalation processes.
  • Support upgrades of TrackWise and participate in UATs.
  • Participate in supplier qualification and quality agreements.
  • Contribute to new product launches and tech transfers.
  • Work across systems: TrackWise, SAP, LIMS.
  • Monitor KPIs and support Quality Management Review Council activities.
  • Foster a strong Quality Culture across the organization.
  • Represent the company during audits and inspections.

 

If you have:

  • Degree in Medical Laboratory Science or Pharmacy.
  • Postgraduate degree in Quality Management.
  • Minimum 8 5 years of experience in pharmaceutical or GxP environments.
  • Excellent knowledge of GMP, ICH guidelines, and pharmaceutical regulations.
  • Experience in Quality Management Systems.
  • Fluent English (spoken & written).
  • Proficiency in MS Office.
  • Strong communication and problem-solving skills.

 

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