You will support and lead quality assurance activities at our Singapore site. You will help maintain and improve our Quality Management System and support manufacturing, training, documentation, and batch release activities. You will work with cross-functional teams and global colleagues to ensure compliance with regulations and company standards. We value people who are curious, practical, and committed to continuous improvement. Join us to grow your skills, make a meaningful impact, and contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Interact with manufacturing personnel in day-to-day operations to ensure cGMP compliance.
Support compliance in production area by routinely conducting QA checks such as checklist review, housekeeping checks, review of line clearance checks, verify compliance with SOPs, etc.
Authorize campaign changeovers and participate in facility walkdown where required.
Provide quality input and assistance in managing unplanned event investigations, CAPA implementation and change control monitoring for project related operations.
Ensure project related changes implemented on production areas are properly managed to prevent potential adverse impact to operations.
QA Authorize processes e.g. Production Process Orders, Quality Tag Outs, Equipment releases, Room releases, CC implementation etc.
Review and approval of LSOPs, checklists, master batch records, deviations, events, CAPAs, change controls, quality tag outs.
Support site complaint investigations, periodic quality review, self-inspections, risk assessments and/ or gap analyses, corporate or regulatory inspections.
Identify and mitigate potential risks (e.g. quality issues) with project team during execution and avoid / minimise disruption to project milestones and routine operations
Mentor and coach junior QA staff to develop strong quality decision‑making skills and ensure effective execution of quality‑related tasks.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
University degree in Science, Engineering or a related discipline.
Minimum 5 years’ experience in Quality Assurance within the life sciences or pharmaceutical industry.
Practical knowledge of current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP).
Hands-on experience with deviations, CAPA, change control and batch review processes.
Strong written and verbal communication skills and experience working with cross-functional teams.
Proficiency with quality systems and electronic document or training platforms. Experience with SAP is a plus.
Preferred Qualification
If you have the following characteristics, it would be a plus
Bachelor’s degree in a relevant science or engineering field if your basic degree is different.
Experience with making quality decisions in a manufacturing setting.
Prior exposure to regulatory inspections and presenting to regulatory or corporate auditors.
Experience owning a site quality system or being a subject matter expert for a quality domain.
Familiarity with quality metrics, trending and site-level quality council activities.
Project or change management experience supporting system implementations or process improvements.
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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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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