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