Senior/ QA Operations Executive at GSK in Tuas

Job description

The purpose of the Senior / QA Operations Executive is to: Provide QA oversight to ensure cGMP compliance is maintained across manufacturing and Quality Control operations and manage quality-related activities including batch usage decisions, deviation management, audits, and release authorizations in line with defined QMS requirements and regulatory standards. Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 1. QA and Quality Oversight Ensure cGMP compliance in day-to-day Manufacturing and QC operations through regular interactions with QC personnel and shopfloor visits. Conduct checklist reviews, housekeeping checks, line clearance, process confirmations, facility walkdowns, and verify SOP compliance. Manage unplanned event investigations, monitor CAPA implementation, and oversee change controls to ensure testing accuracy and prevent adverse impacts on operations. 2. Authorisation Activities: Authorize QA processes such as Quality Tagouts, conditional equipment releases, campaign changeovers, and room releases. Decide compliance status for QC testing, validation issues, batch usage, record closures, and processing or release suitability. 3. Documentation Review and Approval: Review and approve manufacturing and QC documentation, including LSOPs, checklists, analytical protocols/reports, QC monographs, Master Batch Records (paper and electronic), compendial gap assessments, deviations/events/ lab investigations (LIV), CAPAs, change controls, and Quality Tag Outs for compliance with cGMP and regulatory standards.  Ensure accuracy and thoroughness in addressing deviations with practical and robust recommendations. Ensure the quality of executed batch records and monitor accuracy while initiating corrective actions. 4. Investigative and Risk Management Activities: Support site complaint investigations, self-inspections, and audits. Perform risk assessments and gap analyses, provide input for corporate or regulatory inspections, and identify compliance risks/gaps to recommend improvements. Manage deviations and lab investigation reports by providing quality input, ensuring thorough reviews, and supporting investigations of unplanned events to identify root causes. Oversee the implementation of corrective actions (CAPA) related to deviations and lab investigations and monitor their effectiveness to prevent recurrence. Identifying compliance risks/gaps and recommending process improvements. Escalate unresolved or critical compliance issues related to deviations and lab investigations as needed. 5. Training and Subject Matter Expertise: Own and maintain relevant SOPs and checklists, train personnel, and support self-inspections and audits. Act as a subject matter expert (SME), implement quality process improvements, coach junior staff (for Senior position), and stay updated with best practices. 6. Environmental Health and Safety (EHS): Comply with EHS requirements and deliver assigned objectives related to workplace safety. 7. Other QA Support Activities: Support periodic quality product reviews and site key performance indicator (KPI) reporting. Perform internal audits and risk assessments/gap analyses as part of continuous quality improvement efforts. Act as a subject matter expert (SME) to support self-inspections and audits, guiding compliance improvements where necessary. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: 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) Abilit