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.