Jayesh S. Patil

Quality Management System: Evaluation and approval of change controls, deviations, OOS, OOT, market complaints, root cause investigation reports, and ensuring closure with a proper conclusion. Approval of corrective and preventive action based on the outcome of the root cause investigation. Closure of CAPA, and check the effectiveness. Review and approval of the quality risk management report.

Vendor Management: Vendor qualification activities, including the evaluation of vendor documents, the review of vendor sample analysis reports, the management of vendor documents, and the approved vendor list of raw materials and packing materials. Conduct vendor audits of intermediate, KSM, and packing materials manufacturers. Contract manufacturers need to base audit planning, arrangement, execution, and drive audit compliance with earlier status and recommended CAPAs. Follow up to ensure audit compliance on time and make them understand the requirements of cGMP. Close the report after the completion of compliance. Communicate audit results to management through audit reports and quality review meetings.

Management of Standard Operating Procedure: Drove process standardization by creating and implementing SOPs, resulting in increased efficiency, and reduced deviations.

Audits and Compliance: Managing regulatory and customer audits, steered initiatives toward ensuring the implementation of QMS at the site.
Regulatory audits faced: USFDA, EDQM, KFDA, cGMP, and various customers and EHS audits.
Certified as an internal auditor / vendor auditor. Conduct internal audits for all sites, and check the status of compliance. Responsible for the preparation of internal, customer, and regulatory audit responses, and ensuring implementation. Review the compliance report and issue the close-out report.

Training and Development: Certified as a Trainer. Responsible for ensuring the department's training. Planning and conducting training programs for employees across levels and functions, viz. cGMP, Data Integrity, and Other Application Guidelines.

Validation and Qualification: Held accountable for reviewing and approving process validation protocols and reports.
Held accountable for reviewing and approving cleaning validation protocols and reports. Contributions towards the review and approval of equipment qualification documents, such as User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol and report of manufacturing equipment, and checking the execution properly. Review and approval of HVAC qualification. Review and approval of Water System Qualification and Validation.

Project Lead – Pharmaceutical Manufacturing Facility Setup: Led the end-to-end setup of a new GMP-compliant pharmaceutical manufacturing plant, starting from facility layout finalization to operational readiness.

Managed and guided a cross-functional team of nine professionals through planning, execution, and successful closure of projects for a new pharmaceutical facility.

Directed the development and implementation of comprehensive departmental documentation, including SOPs, validation protocols, and quality systems.

Oversaw complete validation activities, ensuring compliance with GMP standards, and regulatory requirements across all processes and systems.

• Faced 3 USFDA and 1 EDQM audits as a Auditee to represent Production, Maintenance and Warehouse dept.
• QMS setup for NEW PLANT. Right from the qualification to start Production.

• Documentation of ONCOLOGY (sterile) plant to compliance for regulatory requirement. Responsible for SAP related activity. (SAP version 7.1)

• GMP coordinator and responsible for preparation of various documents related to production. And active part in review of executed document.

• Work for production and handling overall production activity in shift

• Responsible for handling of various equipment for production like Reactor, Centrifuge, VTD, RCVD, TD, Multi mill, Jet Mill etc.Updating online records for the same.