Quality Assurance Manager

Specific Responsibility, but not limit to : To review and approval of all concerned department master SOPs / GTP / BMR / Spec. & STP of Finished Products, Raw Materials & Packing Materials and its compliance in the System. Implementation and compliance of approved SOPs in the system To ensure quality system are maintain as per ISO requirements and followed by GMP guidelines. To investigate the route cause for Out of specification analytical reports. To handle the market complaint and investigate to find out route cause and in coordination with concerned departments and communicate to management and customer. To review all critical Deviation are investigated and resolved. Review and approval of Change Control. Review and approval of all Validation and Qualification related activities. Review and approval of Vendor Qualification for supplying of Raw Materials / Packing Materials. Review and approval of Batch records and release of finished product. Conduct Internal and External Audit in coordination with all concerned departments Head. Performing Annual Product Quality review. Conducting and organizing of GMP and on-job training.

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