As a Quality Operations Senior Specialist, you will play a key role in the development, implementation and oversight of the Quality Management System within the Quality Operations Department. You will support the preparation of Polpharma Biologics S.A. for pharmaceutical inspections and audits conducted by both national and international regulatory authorities. In this role, you will be responsible for ensuring that processes managed by the department – including batch documentation review – are carried out in full compliance with applicable regulations and internal standards.

Your responsibilities include, but are not limited to:

• Develop, implement, and supervise the Quality Management System.
• Review and approve GMP documentation (internal and from external partners).
• Support preparation for local and international inspections and audits.
• Verify manufacturing processes for GMP compliance.
• Verification of compliance of the GMP documentation in the unit with internal and external regulations before its implementation. Maintaining and developing the quality system in consultation with the Managing Quality Compliance and Operational Quality Compliance Departments.
• Participate in change control, risk analysis, and CAPA processes.
• Conduct and participate in internal and external audits.
• Deliver employee training and support the quality culture across the organization.

If you have:

• Minimum 5 years of experience in the pharmaceutical industry, including at least 2 years in QA or QC.
• Higher education in biology, chemistry, pharmacy, biotechnology, or related fields.
• Strong knowledge of GMP, pharmaceutical law, and ICH guidelines.
• Experience with Quality Management Systems.
• Fluency in Polish and English (written and spoken).
• Ability to make decisions, collaborate in teams, and manage tasks independently.

What we offer:

• Competitive salary.
• Private healthcare.
• Life insurance.
• Pension plan above national standards.
• Additional free day.
• and more..