Total 1 job vacancies by Prestige Biopharma Limited

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