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.
