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Senior QA Executive 1

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GSK

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Location:
Singapore , Tuas

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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

Nice to have:

  • 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
What we offer:
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes

Additional Information:

Job Posted:
February 17, 2026

Employment Type:
Fulltime
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