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