Kerja Sepenuh Masa QA Operations Engineer, Gaji tinggi SGD 8,000 di COALESCE MANAGEMENT CONSULTING PTE. LIMITED - Maukerja

Scope of Work

• Review and approve Change Controls , Deviations , and associated CAPAs to ensure compliance with GMP and site quality requirements.
• Review and approve Master Batch Records (MBRs) and provide QA oversight to support batch readiness and product release activities.
• Review, approve, and maintain Standard Operating Procedures (SOPs) and other GMP documentation, ensuring alignment with regulatory and internal quality standards.
• Provide QA oversight for the qualification and validation of process and laboratory equipment , including the review and approval of equipment lifecycle documentation (e.g. URS, DQ, IQ, OQ, PQ, validation protocols and reports).
• Partner with cross-functional teams including Manufacturing, Engineering, Validation, and QC to ensure validation activities are executed in compliance with GMP and regulatory requirements.
• Support continuous improvement initiatives, audit readiness, and regulatory inspection activities as required.

Requirements

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Life Sciences, or a related discipline.
• 3–5 years of relevant Quality Assurance Operations experience within a GMP pharmaceutical manufacturing environment.
• Hands-on experience with Change Control , Deviation Management , GMP documentation review, and equipment qualification/validation.
• Experience reviewing qualification lifecycle documentation and providing QA oversight for validation activities.
• Prior experience in a sterile drug product manufacturing environment is highly preferred.
• Strong understanding of cGMP, data integrity, and regulatory requirements (FDA, EU GMP, PIC/S).
• Excellent communication, stakeholder management, and problem-solving skills.

Coalesce Management Consulting(CMC) is a leading international consulting partner providing technology, business change, outsourcing and operational support services across the engineering, energy, life sciences and technology sectors