To perform batch release related activities (such as batch release, complaint investigation, product incident management) to maintain cGMP compliance in line with defined quality requirements and regulatory standards. You will work closely with quality operations, supply chain and global quality partners. We value curious, pragmatic and collaborative people who want to grow their skills. This role offers meaningful impact, career growth and the chance to help GSK unite 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:
Provide quality input and assistance in unplanned events investigations, CAPA implementation, SOP reviewing and change control monitoring with batch release implications.
Interact with various functions to ensure cGMP compliance in batch release related operations.
Manage OMCL sample submission for the site.
Manage Internal Quality Agreement (IQA) between GSK Vaccines Singapore site and other GSK sites.
Manage Product Technical Complaints (PTC) & safety signals received from central teams and perform and/or coordinate investigation assigned to the site. Perform also periodic trending and system effectiveness review.
Support product incidents and recall management through preparation and participation according to role assigned in Local Incident Committee (LIC) and Product Incident Review Committee (PIRC), performance of relevant batch traceability and quarantine. Perform also relevant periodic simulations, trending and system effectiveness review.
Other activities as assigned, for examples: Support periodic quality review, perform self-inspections, perform risk assessment and/or gap analysis, support corporate or regulatory inspections eSite KPI reporting.
Act as a Subject Matter Expert for topic identified including:
- Own related SOP and Checklist and train personnel
- Maintain and expertise up to date
- Perform gap assessment/ implementation assessment against corporate or vaccines reference documents
- Support self-inspections and internal audit front during corporate or regulatory inspections.
Basic Qualification:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelor’s degree in science, engineering, pharmacy or a related discipline.
Minimum 5 years of experience in quality assurance within the pharmaceutical, biologics or life sciences industry.
Strong working knowledge of good manufacturing practices and quality systems.
Practical experience in investigations, CAPA and change control processes.
Experience with batch release, product transfer or validation activities.
Good written and verbal communication skills in English.
Preferred Qualification:
If you have the following characteristics, it would be a plus:
In-depth understanding of GMP standard and regulatory requirements of pharmaceutical industry.
Good knowledge of pharmaceutical manufacturing and biological processes
Experience supporting regulatory inspections or audit readiness.
Familiarity with SAP, electronic batch records or laboratory information systems.
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 [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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GSK Singapore, Singapore, SGP Office
Singapore, Singapore, 139234
