Clinical Quality Executive

Job Description: • Ensure clinical trial processes and procedures are conducted in accordance with GCP, relevant regulations, guidelines, protocol, and quality management system • Conduct quality risk assessment and ensure appropriate mitigation of risks • Manage document control of quality management system • Review and update SOPs and associated documents • Prepare and conduct internal process audits, study specific audits, site audits, vendor audits and relevant audit reports • Perform Incident/CAPA lifecycle management including root cause analysis, impact analysis and provide suitable recommendations for improvements • Perform computerized system validation where required • Assist in the conduct of quality management review meetings • Keep up to date with regulatory guidelines and legislations and utilize relevant documents to interpret for guidance • Conduct vendor qualification • Review of relevant clinical trial documents • Management of QMS-related and study-specific training • Other duties as assigned by line manager/HOD Requirements/Skills: • Bachelor’s degree or equivalent in basic sciences • Experience in pharmaceutical industry with knowledge of EU, US and other relevant international regulatory standards and GxP guidelines for the conduct of clinical trials • Experience in clinical/regulatory auditing desirable • Effective oral and written communication skill • Strong analytical and problem-solving skill • Good computer skills, inclined to adapt to technology efficiently • Results-oriented, multi-tasking, quick learner