- Islandwide (Singapore) Singapore
Working Location
Job Description
Responsibilities
Primary Objective / Purpose
To uphold strict GMP compliance, safeguard documentation integrity, and govern the final batch release approval process.
Key Responsibilities
• Review and approve all validation protocols and reports.
• Conduct comprehensive batch record reviews.
• Govern deviations, investigations, and CAPA processes.
• Authorize the release of Engineering Run and PPQ batches.
• Perform internal GMP audits and readiness inspections.
Key Deliverables
• Batch disposition decisions
• Deviation & CAPA reports
• Validation approvals
Required Skills & Qualifications
• Degree in Science or Engineering.
• Extensive knowledge of cGMP regulations and quality systems.
• Experience with eQMS software (e.g., TrackWise, Veeva Vault).
• Strong auditing, problem-solving, and compliance mindset.
Important Information
Never provide your bank or credit card details when applying for jobs. Do not transfer any money or complete unrelated online surveys. If you see something suspicious, Report this Job ad.