The role involves reviewing and approving qualification documentation for facilities, utilities, and computerized systems in accordance with GMP requirements
Job Summary
The role involves reviewing and approving qualification documentation for facilities, utilities, and computerized systems in accordance with GMP requirements.
Candidates must ensure audit readiness and manage deviations related to facilities and utilities within a regulated pharmaceutical environment.
This position requires a minimum of 5 years of relevant experience in the regulated pharmaceutical industry with strong analytical and problem-solving skills.
Matching Summary
The role involves reviewing and approving qualification documentation for facilities, utilities, and computerized systems in accordance with GMP requirements.
Skills & Requirements
Must-have
GMP compliance knowledge
Commissioning and qualification experience
Facilities and utilities validation
Deviation management skills
EMA/FDA regulatory environment
Nice-to-have
Process or cleaning validation experience
Power BI software proficiency
German language capability
Electronic validation tools (Kneat Gx)
Continuous improvement mindset
Key Requirements
Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or related field
Minimum 5 years of experience in regulated pharmaceutical industry
Experience with EMA/FDA regulations and ICH/PIC/S guidelines