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Lead and support site regulatory conformance activities and maintain effective, compliant Quality Systems in line with GSK standards and cGMP requirements, ensuring ongoing inspection readiness and sustained site compliance. Act as the site Subject Matter Expert (SME) and process owner for key quality systems, driving compliance, continuous improvement, and operational effectiveness. Act as the site Subject Matter Expert (SME) for assigned quality systems, driving compliance, continuous improvement, and operational effectiveness.
Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Quality Systems Management
For assigned Quality Systems, including Deviation Management, CAPA, Change Control, Product Quality Review (PQR), Quality Alerts/Bulletins, and Quality Management Systems (QMS):
Act as the site SME and provide guidance to stakeholders on quality system requirements and best practices.
Ensure systems are maintained in compliance with regulatory requirements, GSK policies, QMS standards, and site procedures.
Manage system-related documentation, SOPs, training programs, and periodic reviews.
Support business users and maintain proficiency in relevant SAP and electronic quality management systems.
Conduct gap assessments against global quality standards and drive timely closure of identified gaps.
Partner with global and site stakeholders to share best practices and implement continuous improvements.
Deviation & CAPA Management
Oversee deviation investigations and CAPA activities to ensure timely closure and effectiveness.
Monitor performance metrics, identify trends, and recommend improvements to prevent recurrence.
Present key quality trends and system performance updates to Site Quality Council (SQC).
Product Quality Review (PQR)
Coordinate and maintain compliance with the Global PQR schedule.
Lead the compilation, review, and issuance of Product Quality Review reports and local summary reports.
Ensure product quality trends, risks, and improvement opportunities are effectively captured.
Change Control Management
Facilitate Change Control Board meetings and support effective implementation of site changes.
Ensure appropriate classification, assessment, approval, and closure of changes.
Monitor system health and report key Change Control metrics to Site Quality Council.
Quality Alerts & Quality Bulletins
Coordinate site responses to quality alerts and bulletins, ensuring timely assessment and implementation of required actions.
Monitor compliance and provide updates on quality communications to Site Quality Council.
Quality Management System (QMS)
Serve as the site champion for Quality Management Systems.
Ensure effective implementation of global quality requirements and timely completion of impact assessments.
Monitor and communicate quality risks associated with open compliance gaps.
Regulatory & Site Compliance
Lead regulatory conformance activities and act as SPOC with Global Regulatory Affairs for regulatory compliance matters, supporting submissions, HA responses and impact assessments of site changes and deviations.
Support specialised compliance processes such as Biological Product Deviation Reports (BPDR) and, where assigned, Halal implementation, corrective actions and interactions with external Halal bodies.
Audit, Inspection & Self-Inspection Management
Prepare and lead inspection readiness programmes and external inspections, including backroom coordination and sitewide readiness activities.
Own the site self-inspection process and annual plan, ensuring timely, appropriate closure of audit-related CAPAs and follow-up actions.
Quality Risk Management & Governance
Own and manage the Quality Risk Management (QRM) process, including risk identification, assessment, mitigation, maintenance of the risk register and escalation of significant risks.
Support Management Review and governance by preparing for Site Quality Council (SQC) meetings, aligning KPIs, and compiling, trending and presenting quality system performance metrics and actions.
EHS & Compliance
Comply with all Environmental, Health & Safety (EHS) requirements and promote a strong culture of quality and compliance.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goal.
At least University basic degree in a Science or Engineering discipline.
Preferably 2 years of experience in the pharmaceutical industry in GMP regulated areas and 5 years or more for the role of the Senior QA Executive.
A good understanding of cGMP regulatory and legal requirements, QMS structure and quality assurance for pharmaceutical/vaccine manufacturing and product registration.
A good working knowledge of Deviations, CAPA, change controls and Product Quality Review with hands-on experience will be preferred
To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
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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 APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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