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Lhr Reviewer

2 weeks ago

Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time

**JOB SUMMARY**:
This is an entry-level position within the Quality Systems department. This position requires little or no related experience and will work under close supervision of a qualified peer, Trainer or Supervisor. The incumbent will be responsible for reviewing of Lot History Records, identifying gaps and proactively liaise with production and supply chain department to meet shipment schedules.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**: Include the following. Other duties may be assigned.
- Review Lot History Records (LHR) to ensure compliance with internal and external regulatory bodies and procedures, and customer requirements
- Proactively liaise with cross functional departments to ensure shipment schedule is met
- Identify process gaps and corrective actions
- Implement, Focal Point for all LHR related activities
- Generate Certificate of Conformance (COC) and documentation as required
- Maintain and record product identification and traceability
- Ensure all related documentations are archived, documented to Quality Systems Requirements
- Always align work in accordance with applicable procedural requirements
- Maintain and comply with ISO13485, GMP and FDA regulations

**Education/Experience and Qualifications**

GCE “O” level or higher with 1-year assembly experience