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