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