About the role
AI summarisedGSK is seeking a dedicated QA professional to provide oversight for validation projects across equipment, utilities, facilities, and computerized systems within a contract role. This position requires strong knowledge of cGMP and regulatory guidelines to ensure compliance in validation activities.
BiopharmaOnsiteQuality
Key Responsibilities
- Provide QA oversight for validation projects covering equipment, utilities, facilities, and computerized systems (including CSV lifecycle activities).
- Lead the team on cleaning validation and process validation strategy.
- 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, ensuring timely, compliant closure.
- Approve engineering activities of validated equipment, utilities, facilities, and computerized systems (e.g., calibration, preventive maintenance).
- Support in preparing validation documentation and responding to technical queries for product submission.
Requirements
- Bachelor’s degree in science, engineering, or a related discipline, or equivalent experience.
- 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 the impact of changes, deviations, and corrective actions on validation status.
- Strong communication skills with the ability to work effectively across different functional stakeholders.