You will play a key role in ensuring quality and compliance in a modern manufacturing and project environment in Singapore. You will work closely with operations, engineering, supply chain and global quality partners. We value people who are curious, pragmatic and collaborative. This role offers growth through hands-on work in product transfer, validation and batch decision activities. You will help us 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 QA oversight - Sterility Assurance for site manufacturing processes and products manufactured by the site
Provide QA oversight – Quality control laboratory for Microbiology and Endotoxin tests
Develop, implement, and monitor sterility assurance programme on site
Lead sterility assurance activities: sterile process oversight, container closure integrity (CCI) strategies, aseptic process simulation (media fills), and bioburden or sterility-related investigations.
Develop, review and approve microbiology and sterility-related SOPs, specifications, and test methods; ensure documentation is current and GxP-compliant.
Provide technical direction for microbiology method development, transfer, validation, troubleshooting, root cause analysis, and corrective/preventive actions (CAPA).
Manage deviations, OOS/OOT events and non-conformances related to microbiology and sterility; lead investigations and ensure timely regulatory-compliant reporting.
Establish and maintain environmental monitoring programmes; analyse trends and implement risk-based corrective actions to maintain controlled environments.
Ensure effective quality oversight: participate in internal and external audits, regulatory inspections, and supplier/vendor quality management for microbiology and sterilization services.
Drive continuous improvement initiatives for lab efficiency, data integrity, and robustness of microbiological controls (e.g., automation, digital tools, statistical trending).
Provide training, coaching and competency assessment for aseptic operations personnel.
Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, Validation, Supply Chain, and Regulatory Affairs to support product release and lifecycle activities.
Support risk assessments (e.g., sterility assurance level, contamination control strategy) and change control for microbiology- and sterilization-related changes.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelor’s degree in science, microbiology, biotechnology, pharmacy, engineering, or a related discipline.
At least 6 years of experience in quality assurance within the pharmaceutical or biologics industry.
Strong knowledge of GMP and regulatory requirements relevant to manufacturing and quality.
Practical experience with deviations and CAPA processes.
Experience with validation, qualification and change control practices.
Good written and verbal communication skills in English.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Experience in product transfer or new product introduction activities.
Experience with electronic batch records or laboratory information systems.
Experience working on cross-functional projects or in project QA roles.
Familiarity with SAP or other enterprise quality/ERP systems.
Experience supporting regulatory inspections or audit readiness.
Practical experience in supplier quality management and supplier assessments.
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.
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GSK Singapore Office
Singapore, 139234
