Operational Quality Assurance Senior Specialist

Scope of Duties:

• Participating in the maintenance and continuous improvement of the pharmaceutical quality system in compliance with GMP, EMA, PIC/S, WHO, ISPE, PDA, and EU GMP guidelines.
• Ensuring GMP areas comply with organizational policies and procedures appropriate to the manufacturing readiness stage.
• Preparing and reviewing Quality Assurance documentation and verifying documentation provided by other departments.
• Evaluating changes, conducting investigations, managing deviations, and performing risk assessments.
• Reviewing documentation and audit trails related to manufacturing processes and equipment/installation qualification.
• Participating in health authority inspections, customer audits, and internal audits as assigned.
• Supporting change control, risk analysis, deviation and root cause analysis processes.
• Verifying CAPAs in accordance with procedures.
• Conducting regular checks of GMP areas to ensure compliance with requirements.
• Interpreting and implementing quality assurance standards into internal procedures.
• Collecting and compiling data for Annual Product Quality Review (APQR).
• Analyzing quality data to identify improvement areas.
• Identifying training needs and coordinating training programs to meet quality standards.
• Assessing audit findings and implementing corrective actions.
• Participating in additional projects assigned by the line manager within Polpharma Biologics S.A.
• Working with digital systems such as TrackWise and SAP.

Our Expectations:

• University degree in biotechnology, biology, chemistry, pharmacy or related field.
• At least 4–5 years of experience in the pharmaceutical industry.
• Solid understanding of GMP requirements, pharmaceutical regulations, and quality management systems.
• Strong problem-solving and analytical thinking skills.
• Knowledge of data integrity principles and experience with computerized systems.
• Ability to work under pressure, manage multiple projects, and meet deadlines.
• Excellent verbal and written communication skills in both Polish and English.
• Proficiency in MS Office tools.

What we offer:

• Employment at a company that is a leader in the Polish biotechnology sector, and contribute to life-changing medicines reaching patients globally.
• Collaboration with experts from the world’s leading biotechnology companies.
• Attractive benefits package, including:
  
  • Private healthcare.
  • Life insurance.
  • Employee Pension Program (EPP).
  • Annual and occasional bonuses.
  • Financial support for skills development.
  • Lunch card.
  • One additional day off per year (Polpharma Day).
• And much more...