Quality Assurance Manager

1) Monitoring of Quality assurance functions and overall plant GMP compliance.

2) Review and Approval of Batch manufacturing record and Bath packing records.

3) Review and Approval of standard operating procedures of all department.

4) Self-inspection of all departments and follow of compliance maintain records.

5) Monitoring training of personnel.

6) Monitoring revision and Approval of Master Documents like Validation Master Plan VMP, VMR, Site master file SMF, Method Validation protocol and report.

7) Implementation and Monitoring overall Pharmaceutical Quality System (PQS), Quality Management System, Change Control, Deviation, CAPA, Product Complain.

8) To aware the management with areas of improvements.

9) Monitoring and ensuring overall plant systems, processes and producer are in the state of compliance with respect Qualification, Validation and calibration.

10.Hosting the vendor and Regulatory audits.

11.Approval and release of each batch being manufactured in accordance with the GMP compliance for distribution.

12.To establish, implement & oversite the Basic Development Quality Assurance system in R&D Department.