Clinical Quality Executive

PRESTIGE BIOPHARMA LIMITED; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Prestige Biopharma Limited in Singapore seeks a QA regulatory specialist to ensure clinical trial processes comply with GCP, global standards, and QMS. You will conduct risk assessments, manage document control, and review SOPs and audit reports.

The role requires a science degree, experience in pharma with EU/US regulations, and strong communication and analytical skills. You will support training, vendor qualification, CAPA, and system validation, staying up-to-date with regulatory guidance.

Qualifications

• Bachelor’s degree in basic sciences or equivalent.
• Experience in pharmaceutical industry with knowledge of EU, US and other regulatory standards and GxP guidelines for clinical trials.
• Auditing experience in clinical/regulatory areas desirable.
• Effective oral and written communication skills.
• Strong analytical and problem-solving abilities.
• Good computer skills and adaptability to technology.

Responsibilities

• Ensure clinical trial processes comply with GCP, regulations, protocol and QMS.
• Conduct quality risk assessments and ensure effective mitigation of risks.
• Manage document control within the quality management system.
• Review and update SOPs and related documents.
• Prepare and conduct internal process audits, study audits, site audits and vendor audits.
• Perform CAPA lifecycle management including root cause analysis and recommended improvements.
• Assist in computerized system validation where required.
• Support quality management review meetings and training within QMS and study-specific training.
• Keep up to date with regulatory guidelines and interpret for guidance.
• Conduct vendor qualification and review study-related documents.

Skills

Regulatory knowledge

Auditing

Communication

Analytical thinking

Computer skills

Multi-tasking

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