Clinical Quality Officer

1 week ago

Singapore PRESTIGE BIOPHARMA LIMITED Full time

**Responsibilities**:

- Ensure clinical trial processes and procedures are conducted in accordance with GCP, relevant regulations, guidelines, protocol, and quality management system
- Assist with the management of QMS and related activities e.g. account management
- Document control of quality management system
- Review and update SOPs, forms, and templates
- Assist in internal process audits, study specific audits, site audits and preparation of audit reports
- Assist in CAPA management, root cause analysis and provide suitable recommendations for improvements
- 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
- Assist in vendor selection audit procedures and vendor oversight assessment reviews
- Review of essential documents for clinical trials and documents for regulatory submission
- Management of QMS and study related trainings
- Assist with risk management/ assessments
- Perform other related duties as assigned

**Skills and Qualification**
- A bachelor’s degree in a science related
- A minimum of 1 years’ experience in a clinical research (GCP) role
- Strong analytical and critical thinking skills
- Ability to exercise good judgement under pressure and tight deadlines
- Strong communication and inter-personal skills
- Flexible in adapting to variety of responsibilities and work assignments.

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