Clinical Quality Leader – GxP & Audits

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

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.