Clinical Quality Executive

PRESTIGE BIOPHARMA PTE. LTD.; Singapore; On-site; SGD 65,000 - 95,000; Full time

Job summary

Prestige Biopharma Pte. Ltd. in Singapore is seeking a Quality Assurance / Regulatory Auditor to ensure clinical trial processes comply with GCP, regulations and the company's QMS. The role focuses on risk assessments, audits, document control and training support.

You will review SOPs, manage CAPA, and stay current with regulatory guidelines to guide study teams. Strong written and verbal communication, analytical skills, and proficiency with computer tools are essential.

Qualifications

• Bachelor’s degree in basic sciences or equivalent.
• Experience in pharmaceutical industry with knowledge of EU, US and other regulatory standards and GxP.
• Experience in clinical/regulatory auditing is desirable.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving abilities.
• Proficient with computers and adaptable to new technology.

Responsibilities

• Ensure clinical trial processes comply with GCP, regulations and QMS.
• Conduct quality risk assessments and implement mitigations.
• Manage document control within the QMS.
• Review and update SOPs and related documents.
• Prepare and conduct internal and site audits and report findings.
• Lead CAPA lifecycle management including root cause analysis.
• Perform computerised system validation where required.
• Support quality management review meetings.
• Stay updated with regulatory guidelines and interpret for guidance.
• Conduct vendor qualification and qualification reviews.
• Review clinical trial documents for quality and compliance.
• Coordinate QMS-related and study-specific training.
• Handle any other duties assigned by line manager/HOD.

Skills

Communication

Analytical thinking

Problem-solving

Computer skills

Multi-tasking

Fast learner

Education

Bachelor’s degree in basic sciences

Job description

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