About the role
AI summarisedEnsure quality compliance in manufacturing and Quality operations, providing leadership to operational quality functions. This role is vital for overseeing production activities, managing batch documentation, and handling the release of finished products to ensure consistent adherence to cGMP standards and regulatory requirements.
BiopharmaOnsiteQuality
Key Responsibilities
- Accountable for ensuring products are manufactured and released according to the regulatory dossier and cGMP standards.
- Ensure compliant review of batch records, lab results, and release documentation.
- Oversee investigations for deviations, lab events, complaints, returned goods, and product failures, including assessing impact and ensuring CAPA effectiveness.
- Provide shift-based Quality oversight of facilities, equipment, and operations to assure real-time cGMP compliance and ALCOA+ data integrity.
- Ensure quality-related systems, policies, and procedures across the site are relevant and compliant with regulatory and GSK requirements.
- Support inspections, sustain acceptable audit status, and drive CAPA development and closure monitoring.
- Manage, develop, and train staff while driving quality performance metrics and batch documentation lead time.
Requirements
- Bachelor’s degree in life sciences, pharmacy, engineering, or a related technical field.
- Minimum 7 years’ experience in pharmaceutical, biopharma, or related regulated manufacturing quality/operations roles.
- Practical experience with Quality Management Systems and Good Manufacturing Practice (GMP) requirements.
- Demonstrated experience managing deviations, CAPA, change control, and investigations.
- Strong written and verbal communication skills in English with the ability to present objective findings.
- On-site presence required at the manufacturing site in Singapore.