This role serves as a key quality partner ensuring facilities, systems, and processes meet the highest standards to safeguard medicine quality and safety
Job Summary
This role serves as a key quality partner ensuring facilities, systems, and processes meet the highest standards to safeguard medicine quality and safety.
The specialist provides critical oversight on qualification and validation tasks across facilities, utilities, equipment, and computerized systems while managing deviations and change controls.
Candidates must possess strong communication skills to collaborate with engineering, manufacturing, and quality control teams in a dynamic regulated environment.
Matching Summary
Match Score: 85
This role serves as a key quality partner ensuring facilities, systems, and processes meet the highest standards to safeguard medicine quality and safety.
Skills & Requirements
Must-have
5-7 years pharmaceutical validation experience
Facilities Utilities Equipment FUE validation
Computerized systems validation expertise
Manufacturing process validation knowledge
Regulatory compliance FDA EMA standards
Validation documentation protocol report review
Nice-to-have
Sterile or aseptic manufacturing environment exposure
Health authority inspection support experience
Data integrity principles ALCOA+ knowledge
Electronic document management system familiarity
Technology transfer activity background
Proactive continuous improvement mindset
Key Requirements
Bachelor's degree in Science Engineering Pharmacy
Minimum 5-7 years relevant industry experience
Hands-on validation experience for FUE and processes