Clinical Quality Executive

PRESTIGE BIOPHARMA PTE. LTD.; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Prestige Biopharma Pte. Ltd. is seeking a Quality Assurance professional to ensure clinical trial processes comply with GCP and global regulatory standards. You will manage QMS document control, SOP reviews, and various audits to ensure data integrity and compliance across trials.

The role requires a strong background in regulatory guidelines, analytical problem solving, and excellent communication skills to interpret guidelines and implement effective improvements.

Qualifications

• Bachelor's degree or equivalent in basic sciences.
• Experience in pharmaceutical industry with knowledge of EU, US and other regulatory standards (GxP).
• Experience in clinical/regulatory auditing is desirable.
• Effective oral and written communication skills.
• Strong analytical and problem-solving abilities.
• Good computer skills and adaptability to new technology.

Responsibilities

• Ensure clinical trial processes and procedures comply with GCP, regulations, protocol, and QMS.
• Conduct quality risk assessments and mitigations.
• Manage document control of the quality management system.
• Review and update SOPs and related documents.
• Prepare and conduct internal audits and site/vendor audits; report findings.

Skills

Communication skills

Analytical skills

Computer literacy

Multitasking

Education

Bachelor's degree or equivalent 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