Jayeshkumar Chaudhari Email & Phone Number

Port Coquitlam, British Columbia, Canada

Maple Ridge, British Columbia, Canada

Gujarat, India

• Maintained workflow by monitoring steps of the production process and performed planning, monitoring, and observing control points, personnel, and resources.• Cleaning validation:  Incorporated new cleaning method in production area by using a new cleaning agent to nullify chances of traces carry over to next manufactured products and impurity generation. Carried out Equipment grouping and Worst case product identification Identified difficult to clean, moderate to clean and easy to clean locations in production area equipments and accordingly swab sampling locations indentified for cleaning validation activity. Prepared cleaning validation protocol as per equipment group and calculated MACO value & PDE value to fix the acceptance criteria Carried out recovery study on different materials for identified worst case APIs. Carried out swab sampling activity at different stages for chemical testing and Microbial testing. Carried out cleaning validation activity protocol execution, data compilation and summary preparation. Carried out CEHT (Clean Equipment Hold Time) and DEHT (Dirty Equipment Hold Time) study in production area equipments. Prepared cleaning verification matrix for yearly cleaning verification and data compiled after completion of study• Equipment and instrument qualification: Prepared URS (User Requirement Specification) to match with user requirements.  Prepared Quality Risk Management document Performed FAT, prepared Design Qualification, Installation qualification, Operational Qualification and Performance qualification protocols to verify the functionality of equipment to deliver quality product consistently. Prepared and executed password protection policy and user management policies during equipment qualification  Summarized and compiled the qualification results to finalize the equipment operating parameter range.• Prepared SOPs for cleaning of equipments and accessories to avoid cross-contamination.

Dhar, Madhya Pradesh, India

• Organized and evaluated entire plant operation and dispatchplanning• Maintained QMS system in department by initiation of change control, deviations and CAPA Implementation Change control: Identified of nature of change by performing impact assessment, documented work flow prepared to complete the proposed changes and listed out impacted documents and other facilities, Evaluated and proposed target completion date to implement the change.  Deviation: Identified deviations and categorized them as per criticality, investigated deviations by 5 why analysis, Ishikawa diagram method and 6M method to identify the root cause, CAPA implementation to avoid re-occurrence of deviation and CAPA verification.• Conducted safety audits and self inspections to suggest any change in machine parts and manufacturing methods• Interacted with Quality Assurance and Quality control team for quality inspections• Reviewed SOPs to identify any loop holes and took corrective actions.• Work allotment to juniors (Total: 58 persons worked simultaneously under my supervision)• Identified hidden skills in team member and proper utilization of work force• Lead the regulatory audit inspections like USFDA and WHO in manufacturing section.

Ahmedabad, Gujarat, India

• Monitored manufacturing activities for timely delivery of products• Established budgets and controls in terms of Financial management • Developed and maintained schedules for equipment maintenance• Trained new joined employees for proper and safe way of working in area• Dispensed Active Pharmaceuticals and raw materials for manufacturing of the batch• Planning and execution of exhibit, scale up and validation batches