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Key Responsibilities:
1.ISO / IMS Governance & Compliance
-SOPs, Work Instructions, Forms
-Document control and version management
-Fully documented
-Traceable and auditable
-Internal audits
-External audit preparation (ISO, regulatory)
2.Documented Operational Control
-No activity is executed outside documented procedures
-Batch records
-Material traceability records
-Procurement documentation
3.Deviation, CAPA & Continuous Improvement
-Deviation reporting system
-Root cause analysis framework
-Corrective & Preventive Actions (CAPA)
4.Regulatory Compliance Integration
-NEA/SCDF/ SPF and other regulatory requirements
-Regulatory obligations embedded into daily SOPs
-Licence conditions
-Chemical tracking and reporting
5.Internal & External Audit Management
-Production representative for ISO audits
-ISO certification audits
-Customer audits
-Regulatory inspections
6.End-to-End Traceability Control
-Supplier — Incoming — Production — Delivery
-Procurement records with production batch records
7.Supplier Quality & ISO Alignment
-Quality and regulatory requirements
-Approved Supplier List (ASL)
-Supplier evaluation records
8.Training & Competency Control
-All staffs are trained on SOPs and ISO procedures
-Training records
-Competency assessments
9.Records Management
-Retention
-Traceability
-Retrieval of records
-Production
-Procurement
-Compliance activities
Requirements Required:
Job ID: 151310281