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