Quality Assurance Asst.Manager

Job Responsibilities

• Ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation.
• Provide guidance to QA and cross functional department for compliance to various International CGMP requirements, Co-ordination with departments HOD to implement current GMP in Plant.
• Ensure execution and timely completion of Qualification and Validation Activities and their report Approvals for all the departments.
• Authorized documents but not limited to - Qualifications, Validation Protocols, Reports, all departments SOPs and level I documents for the plant.
• Authorized to release the batch for sales in domestic market as well as per marketing norms and requirements in export market.
• Ensure Critical and Major Changes in the plant for Process, facility and system, execute in a controls manner, that the validated status of Process, facility and System, after changes will remain validate.
• Authorized to approval of Certificate of Analysis.
• Ensure Product Complaints, Product Recalls are responded in time and investigated with proper rationale and justified manner.
• Handling of Customers & Regulatory Audits, timely responses to their observation and effective implementation of corrective and preventive actions.
• Ensure Vendor Qualifications are performed as per requirements, and availability of current update of approved vendor list to concern department.
• Ensure Self-Inspections are conducted as par per-approved schedule, timely closed of observation for all the departments.
• Ensure that products are manufactured as per approved process, Ensure online documentation with respect to activity and execution.
• Ensure IPQA activities in Shop Floor. Planning & Management of Routine Activities during Production & Packing.
• Trained to IPQA & Validation Persons on their Specific Activity & Ensure the Person are well qualified on the Activity before Execution.