Senior/ QA Operations Executive
GSK · Singapore - Tuas ·
- Seniority
- Senior
- Category
- QA
- Experience
- 2+ years
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)
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
To learn more about Singapore GSK and our people, please click on this link:
#Li-GSK
Skills
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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