COALESCE MANAGEMENT CONSULTING PTE. LIMITED

Discussion

QA Operations Engineer

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.
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