Development QA Specialist / Specjalista Zapewnienia Jakości Rozwoju

As we continue to grow, we are looking for a quality-focused professional to support our Technical Development and MS&T departments. If you have experience in pharmaceuticals or biotechnology and a passion for building and optimizing quality systems – we’d love to hear from you!

Your responsibilities include:

• Participating in the development, implementation, and monitoring of the Quality Management System (QMS) in the Technical Development and MS&T departments.
• Ensuring that procedures comply with the Development Quality Manual, EMA/FDA guidelines, and Polpharma Biologics standards.
• Monitoring the effectiveness of QMS implementation through internal audits and training sessions.
  Supporting development departments in executing quality-related processes.
• Assisting with inspection and audit preparation, participation in audits/inspections, and follow-up actions.
• Reviewing and approving research documentation (USP, DSP), both internal and from external partners.
• Implementing new procedures and solutions to ensure data integrity.
• Providing support during root cause analysis and CAPA related to quality events/deviations.
• Conducting training sessions and promoting a strong quality culture across the organization.
• Reviewing audit trails from analytical and process lab devices to ensure data integrity in computerized systems.

If you have:

• A university degree in biology, chemistry, pharmacy, biotechnology, or a related field.
• At least 3 years of experience in the pharmaceutical industry, preferably in Quality Assurance or Quality Control.
• Experience in analytical, biotechnology, and/or quality control laboratories.
• Strong knowledge of GMP, pharmaceutical law, and ICH, FDA, EMA guidelines.
• Practical understanding of Quality Risk Management systems and risk-based approaches.
• Familiarity with the concept of Data Integrity.
• Experience with computer system validation and laboratory equipment qualification.
• Fluency in both Polish and English (spoken and written).

What we offer:

• A position in one of the most advanced biotechnology companies in Poland.
• The opportunity to shape innovative quality solutions in a dynamic environment.
• Competitive salary tailored to your experience and qualifications.
• Private healthcare, life insurance, additional day off, and other benefits.
• A workplace rooted in knowledge-sharing, collaboration, and a strong quality culture.