Location
Tuas, Singapore
Department
Quality
Posted
2 days before
About This Role
A Senior QA Validation Executive contract role at GSK in Tuas, Singapore, requiring 5+ years experience with cGMP and regulatory compliance to oversee equipment validation, lead cleaning strategies, and approve engineering changes.
Responsibilities
- Provide QA oversight for equipment and computerized systems (including CSV lifecycle activities) under new product introduction.
- Lead the team on cleaning validation strategy and execution for major projects.
- Author, review, and approve validation plans, protocols, reports, and related SOPs.
- Assess the impact of changes, deviations, and investigations on validation status.
- Act as QA approver for deviations, CAPAs, change controls, and SOPs to ensure timely closure.
- Approve engineering activities such as master data, calibration, and preventive maintenance strategy.
Requirements
- Bachelor's degree in science, engineering, or related discipline.
- Minimum 5 years' experience in pharmaceutical quality assurance, validation, or related roles.
- Practical knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements.
- Experience in authoring and approving validation documents and SOPs.
- Experience in assessing impact of changes, deviations, and corrective actions on validation status.
- Strong communication skills with the ability to work effectively across stakeholders of different functions.