The role involves leading full life-cycle validation of pharmaceutical manufacturing equipment and facilities to ensure strict regulatory adherence
Job Summary
The role involves leading full life-cycle validation of pharmaceutical manufacturing equipment and facilities to ensure strict regulatory adherence.
Candidates will coordinate cross-project activities and manage teams to deliver successful audit outcomes across multiple high-profile projects.
The company offers a clear career progression path with regular international compliance training and opportunities to participate in major regulatory certifications.
Matching Summary
Match Score: 85
The role involves leading full life-cycle validation of pharmaceutical manufacturing equipment and facilities to ensure strict regulatory adherence.
Salary
Base: S$3500–7000; Bonus/Equity: Annual performance bonus included; Benefits: CPF contribution, 14 days annual leave plus additional company leave
Skills & Requirements
Must-have
GMP compliance and validation expertise
ISPE GAMP5 and PDA guidelines proficiency
Validation Master Plan preparation skills
Cleanroom validation and environmental mapping
HVAC balancing and commissioning experience
Nice-to-have
Fluent English communication for international meetings
Experience responding to FDA 483 observations
Team management in cGMP environments
Track record in EMA/FDA regulatory inspections
Technical training delivery capabilities
Key Requirements
Diploma or Bachelor's degree in Engineering or Life Sciences
Minimum 5 years of pharmaceutical GMP validation experience
Minimum 2 years of team management experience
Proficiency in ISPE, GAMP5, and PDA TR series guidelines