Girish Misal

I am chemical engineering graduate from Pune University of Maharashtra India having 16 years experience in API pharma & primary packaging industries in Quality department 

1.Review of plant documents, Quality System Manual, Site Master File & Technical File. 

2. Approval of plant documents, Quality Management System and records. 

3. Assurance of Implementation of Quality Management System as per the process and regulatory requirement 

4.Responsible for Management Review and worked as plant Management Representative (MR). 

5. Ensuring the timely closure QMS activities like Change Control, CAPA, OOS, Deviations, Management Review and Customer Complaints. 

6. Responsible for regulatory, customer and internal audits compliance and proper justification as per the requirement by notified bodies. Timely completion of audit response and closure of Non-conformance, review and provide the documents as per requirements. 

7 .To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements and making recommendation for improvement as appropriate. 

8 Approval of contract and sub-contract supplier quality agreements. 9 Responsible for timely implementation CAPA and effectiveness checks.

 10 Responsible for handling Indian as well International Regulatory for providing information as per the requirement, queries as and when required. 

11 Responsible for sterilization as well as Microbiological related activities, globally for managing, implementation and approval for documentation (validations protocols, reports) and process specification. 

12 Providing and implementation of Indian as well as International regulatory updates, inputs within the manufacturing plant and marketing team as and when required (CGMP).

 13 Responsible for providing supports for customer complaints throughout the global suppliers. 

14 Approval of validation Protocol and reports. 

15 Responsible for approval and rejection of finished product as per the specifications.

Bachelor of chemical engineering