Site Name: Singapore - Tuas

　　Posted Date: Dec 11 2023

　　 Purpose To lead and manage Site validation activities (as assigned) to ensure that validations are in compliance with company procedures, regulatory requirements, and cGMP expectations.To provide QA compliance oversight over IT and Technical Services (as assigned) Key Responsibilities Area Ensure site validation activities are compliant with Site procedures, regulatory requirements, and cGMP expectations.Provide QA Oversight to IT operations in areas of: QA consultation to review and approve SOPs. Review and approve changes, deviations and CAPAs.Provide QA compliance oversight to Technical ServicesInterface with Internal & External stakeholdersComply with company requirements on EHSProposals & RecommendationsPropose validation approach.Propose areas of site validation improvementIdentify potential compliance risk/ gaps and recommend improvements.Identify improvement in quality processes. Skills, Knowledge & Experience

　　At least University basic degree in a Science or Engineering disciplineAt least 2 years' experience in pharmaceutical industry or related regulatory fields (at least 5 years for Senior QA Validation Specialist role)A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturingGood understanding of regulatory inspection requirementA good working knowledge of validation, preferably with hands-on experienceComputer skills in MS Office and familiar with web-based e-learning resourcesPotential or developing project management skills.#Li-GSK

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