Description
As a Validation Specialist at GSK's Singapore site, you will support and lead validation activities for major projects, ensuring compliance with quality systems and working closely with manufacturing and cross-functional teams. The role involves providing QA oversight for validation projects, authoring and reviewing validation plans, protocols, and reports, and acting as a QA approver for deviations and change controls.
Responsibilities:
- Provide QA oversight for validation projects covering cleaning validation and process validation strategy and execution
- Author, review, and approve validation plans, protocols, reports, and related SOPs
- Assess validation impact for changes, deviations, and investigations
- Act as QA approver for deviations, CAPAs, change controls, and SOPs
- Provide subject-matter expertise to cross-functional teams on validation strategy and execution
- Support preparation of validation documentation and respond to technical queries for product submission
- Apply up-to-date knowledge of regulatory guidance and ensure validation practices reflect industry best practice
Requirements:
- Bachelor's degree in science, engineering, or a 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
Preferred Qualifications:
- Experience with equipment and computerized system validation
- Prior role involved in validation strategy for new product introduction or technical transfer projects
- Project management experience and familiarity with continuous process verification approaches
- Practical understanding of quality management systems and audit processes