Quality Assurance Officer

4 days ago

Singapore INTRINSEQUE HEALTH PTE. LTD. Full time

**Job Description**:
Quality Assurance Officer - Clinical Supply Chain

**Applicant should have experience working with a Contract Research Organisation (CRO), Clinical Supply Chain Organisation, Biotechnology or a Pharmaceutical Drug Development company**

Primary Responsibilities
- Ensure that all processes contributing to the performance of a clinical supply chain activities are conducted properly.
- Troubleshoot clinical supply chain projects and activities.
- Manage and maintain databases for the quality system.
- Prepare and assist in preparing annual reports and quality trending reports.
- Report the status of the quality levels of staff, systems and production activities.
- Preside over improvement programs.
- Evaluate quality events, incidents, queries, and complaints.
- Keep up to date with all related quality legislation and compliance issues
- Compile and prepare materials for submission to regulatory agencies.
- Document internal regulatory processes.
- Ensure regulatory rules are communicated through corporate policies and procedures.
- Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
- Ensure that investigator, vendor, facility and system audits are conducted.
- Communicate any critical compliance risks noted from these activities to senior management.
- Assume a lead role for the preparation, conduct, and responses to regulatory agency.
- Provide leadership and strategy in line with global strategic objectives.
- Follow and maintain the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
- Support clinical staff to implement the deviation process
- Support Risk Management Plans for clinical activities
- Support risk management and risk mitigation activities
- Interact with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues

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