MANISH KUMAR

LEAD ROLE

• Leading a team (2 Executives) involved in preparation of Annual Product Quality Review .
• Leading a team (3 Executives) involved in investigation of Market Complaint .
• Leading a team (1 Sr. Executive and 6 Executives) involve in handling of Document Cell Management .
• Leading a team (1 Sr. Executive and 1 Executive) involve in Commercial Batch Release and preparation of risk assessment report of Elemental Impurity and nitrosamine impurity .

REVIEW AND APPROVAL ROLE

• Responsible for Quality Assurance review and approval of Change Control, Deviation, Market Complaint and Corrective and Preventive Action of site in Quality Assurance Management System .
• Responsible for Site Audit Compliance and Global Compliance in coordination with other departments.
• Responsible for timely initiation of Field Alert Report and Recall from site.
• Responsible for presenting Site Quality Council Meeting to Management and finalize site presentation for Corporate and Global Quality Council Meeting.
• Responsible for Quality Assurance approval of site Standard Operating Procedure .
• Responsible for final approval of Commercial Batch Release from site.
• Review and approval of Protocol and Report of Hold Time, Temperature Cycling Study and Transportation Study.
• Review and approval of risk assessment report of Elemental Impurity and nitrosamine impurity.

ADDITIONAL ACTIVITY HIGHLIGHTS

• Certified Internal auditor for Self-Inspection, Walk the talk Program and Vendor audit .
• Certified Trainer and departmental training Coordinator .
• Completed project for implementation of Document Cell Management System.
• Leading the project for implementation of EDMS (Software for document preparation) at site.

• In-Process Quality Assurance activity in Manufacturing and Packaging process of OSD unit
• Annual Product Quality Report preparation (Approx. 50 Products)
• Process Qualification Protocol and Report preparation
• Laboratory and Manufacturing investigation of Out of Specification and Out of Trend results

ADDITIONAL ACTIVITY HIGHLIGHTS

• Handled the project of re-establishment of Cleaning Validation with new approach of Permitted Daily Exposure.
• Performed Quality Risk Management of OSD Facility.
• Performed vendor audit of API manufacturing site.