Senior QA Operations Lead | cGMP Compliance & Release

GlaxoSmithKline Pte Ltd; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

GlaxoSmithKline Pte Ltd in Singapore seeks a Senior / QA Operations Executive to provide QA oversight ensuring cGMP across manufacturing and QC operations. You will manage deviations, CAPAs, audits, and release authorizations while aligning with QMS and regulatory standards.

The role involves authorising QA processes, reviewing batch records, and supporting investigations. You will train staff, maintain SOPs, and contribute to site quality improvements and safety objectives.

Qualifications

• QA Executives: Minimum 2 years of experience within pharmaceutical, biotechnology, medical device or related regulated industry.
• Senior QA Executive: Preferably 5 years of experience within pharmaceutical, biotechnology, medical device or related regulated industry.
• Good understanding of GMP standard and regulatory requirements of pharmaceutical industry
• User experience with Quality Management Systems (QMS)
• Ability to communicate effectively within the site
• Ability to apply risk management skills and risk based approach adequately
• Ability to apply quality assurance standards and to promote quality as a competitive advantage.
• Ability to solve simple / lower impact investigation

Responsibilities

• Provide QA oversight to ensure cGMP compliance across manufacturing and QC operations.
• Manage quality-related activities including batch usage decisions, deviation management, audits, and release authorizations in line with QMS requirements and regulatory standards.
• Authorize QA processes such as Quality Tagouts, conditional equipment releases, campaign changeovers, and room releases.
• Review and approve manufacturing and QC documentation, including LSOPs, checklists, analytical protocols/reports, QC monographs, Master Batch Records and CAPAs.
• Manage deviations and lab investigation reports, support investigations and identify root causes.
• Support site complaint investigations, self-inspections, and audits; perform risk assessments and gap analyses.
• Own and maintain relevant SOPs and checklists; train personnel; act as SME to implement quality process improvements.
• Comply with Environmental Health and Safety (EHS) requirements and assist in KPI reporting and internal audits.

Skills

Data Integrity

Detail Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Job description

GlaxoSmithKline Pte Ltd in Singapore seeks a Senior / QA Operations Executive to provide QA oversight ensuring cGMP across manufacturing and QC operations. You will manage deviations, CAPAs, audits, and release authorizations while aligning with QMS and regulatory standards.

The role involves authorising QA processes, reviewing batch records, and supporting investigations. You will train staff, maintain SOPs, and contribute to site quality improvements and safety objectives.