Activities and responsibilities

Your main tasks include:

• Plan, execute, and document qualifications (DQ, IQ, OQ, PQ) for equipment, computerized systems, and critical premises.          
• Create and review qualification and calibration documents in accordance with GMP guidelines.
• Maintain and improve the procedures for qualification. 
• Coordinate and supervise external service providers involved in qualification projects.
• Support risk assessments and prepare deviation and change control documentation.
• Collaborate closely with departments such as QC, CSV, IT and R&D.
• Participate in internal and external audits as well as regulatory inspections.

Qualification profile

• Degree in a scientific, technical, or pharmaceutical field (e.g., Pharmacy, Biotechnology, Process Engineering, Chemistry).
• 5+ years of professional experience in qualification within the pharmaceutical industry (e.g., HPLC, Capillary Electrophoresis systems and cleanrooms).
• Solid knowledge of GMP regulations and relevant standards (e.g., EU GMP, US GMP, Annex 15, ICH Q9/Q10).
• Experience with analytical computerized systems and electronic inventory systems is a plus. 
• Structured, independent, and solution-oriented working style.