QA Operations Lead — cGMP Compliance & Quality

No deviation Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

No deviation Pte Ltd is seeking a QA Operations Executive to oversee cGMP compliance across Manufacturing and Quality Control, ensuring product quality and regulatory readiness.

You will manage deviations, CAPAs, change controls, and review GMP documentation while supporting continuous improvement of the QMS. The role requires a Bachelor in Life Sciences or related field and at least 2 years of QA experience in regulated industries.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or a related technical discipline.
• Minimum 2 years of QA experience within the pharmaceutical, biotechnology, medical device, or other regulated industries.
• Good understanding of GMP, cGMP, and pharmaceutical regulatory requirements.
• Experience working with Quality Management Systems (QMS).
• Strong documentation review and GMP compliance experience.

Responsibilities

• Provide QA oversight for Manufacturing and QC operations to ensure compliance with cGMP, regulatory requirements, and internal quality standards.
• Perform routine shopfloor quality oversight including housekeeping inspections, line clearance verification, process confirmations, facility walkdowns, and SOP compliance checks.
• Manage deviations, laboratory investigations, CAPAs, change controls, and risk assessments to ensure timely resolution and effective corrective actions.
• Authorize quality-related activities including Quality Tag Outs, conditional equipment releases, campaign changeovers, room releases, batch usage decisions, and release suitability.
• Review and approve GMP documentation including SOPs, analytical protocols and reports, Master Batch Records (paper and electronic), QC monographs, checklists, deviations, investigations, CAPAs, change controls, and validation documentation.
• Ensure batch documentation is complete, accurate, and compliant, initiating corrective actions where necessary.
• Support complaint investigations, internal audits, self-inspections, regulatory inspections, and quality risk assessments.
• Identify compliance gaps, recommend process improvements, and escal...
• Own and maintain quality procedures, SOPs, and checklists while delivering training to relevant personnel.
• Act as a Subject Matter Expert (SME) for quality processes and support continuous improvement initiatives.
• Support Quality Product Reviews (QPR), quality metrics, KPI reporting, and other Quality Management System activities.

Skills

QA oversight

GMP compliance

Deviation management

CAPA

Documentation review

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related discipline

Tools

QMS software

Job description

No deviation Pte Ltd is seeking a QA Operations Executive to oversee cGMP compliance across Manufacturing and Quality Control, ensuring product quality and regulatory readiness.

You will manage deviations, CAPAs, change controls, and review GMP documentation while supporting continuous improvement of the QMS. The role requires a Bachelor in Life Sciences or related field and at least 2 years of QA experience in regulated industries.