About the role
AI summarisedThis is a QA Executive/Senior QA Executive role at GSK's Singapore site, focusing on validation activities for new product introductions and product transfers in a pharmaceutical manufacturing environment. The role involves providing QA oversight for equipment, utilities, facilities, and computerized systems, leading cleaning and process validation strategies, and ensuring compliance with cGMP and regulatory requirements.
BiopharmaFull-time{'name': 'Quality'}
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, alarm management).
- Provide subject-matter expertise to cross-functional teams (Engineering, Operations, IT, Regulatory) on validation strategy and execution.
- Support in preparing validation documentation and responding to technical queries for product submission.
- Apply up-to-date knowledge of regulatory guidance (cGMP, 21 CFR Part 11, ICH) and ensure validation practices reflect industry best practice.
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 impact of changes, deviations and corrective actions on validation status.
- Strong communication skills with the ability to work effectively across stakeholders of different functions.
- Experience with computerized system validation
- Experience with method validation and pharmacopeia requirement
- Prior role leading or 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.