Clinical Quality Executive

Prestige Biopharma Group (Prestige Biopharma / Prestige Biologics); Singapore; On-site; SGD 70,000 - 130,000; Full time

Job summary

Prestige Biopharma Group in Singapore seeks a QA professional to ensure clinical trial processes comply with GCP, regulations and the company’s quality Management System. You will review SOPs, manage document control, and conduct audits including study, site and vendor assessments.

You will drive CAPA lifecycle management, perform risk assessments, assist in regulatory reviews, and stay current with global guidelines to interpret requirements for trial documentation and training.

Qualifications

• Bachelor’s degree in basic sciences required.
• Experience with EU/US/regulatory standards and GxP guidelines for clinical trials.
• Experience in clinical/regulatory auditing desirable.
• Effective oral and written communication skills.
• Strong analytical and problem-solving skills.
• Good computer skills; quick to adapt to technology.

Responsibilities

• 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
• Review of relevant clinical trial documents
• Management of QMS-related and study-specific training
• Other duties as assigned by line manager/HOD

Skills

Oral & written communication

Analytical skills

Problem solving

Multi-tasking

Quick learner

Computer literacy

Education

Bachelor’s degree in basic sciences

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
• 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