Kalpesh Kolhar

About Kalpesh Kolhar

A competent individual with approx.12 years of experience in various functional areas of…

Experience

1. Executive

   Torrent Pharmaceuticals Ltd

   Dec 2021 — Present · Bharuch, IN

   Job Profile:1. Manufacturing Execution System (MES):• Working as team member for eBMR and eBPR (Software - Syncade | Emerson In 9.0)• Designing of master batch record (MBR) in Syncade system with respect to captureall scenario regarding to existing process.• Knowledge of Equipment Master and Custom property updation of equipment in Syncade system.• Knowledge about Preparation, checking and validation of BMR recipe in Syncade system.• Troubleshooting during execution using SFC workflow.• Training and Execution Syncade Software by Emerson for eBMR and eBPR.2. Equipment Qualification and Computerized System Validation:• Responsible for Equipment Qualification and Computerized System Validation as per SOP and GAMP5, 21 CFR Part 11 compliance, GMP and cGMP.• Responsible for URS, DQ, IQ, OQ, PQ of equipment and computerized system.• Preparation of Protocols and Test scripts for Equipment and Computerized Systems and Execution of Protocol and Test scripts and review of validation documents.• Responsible for impact assessments, GxP assessment, FLRA, SLRA, requirement Traceability Matrix, Validation summary report and Qualification summary report.• Responsible for discrepancies during execution and its criticality.• Authorization matrix and password management.• Responsible in analyzing possible issues Risk assessment and mitigation.• Ensures that CSV and qualification activities being carried out in accordance with internal procedures and applicable regulatory requirements.• Handling Local Administration for Track Wise System, Learning Management System (LMS) and Document Management System (DMS) and SAP transactions.• QMS like Change management (Change control), Deviation and investigation.• Management and co-ordination of Change Control Procedure, Impact assessment.• Preparation, Training and implementation of all SOP related to Quality and Production using Document Management System.

Skills

• Social Media
• Regulatory Affairs
• Microsoft Office
• Gmp
• Marketing
• Microsoft Word
• Manufacturing
• Microsoft Excel
• Powerpoint
• Training
• Research
• Leadership
• Public Speaking
• Pharmaceutical Industry
• Sop
• Sap
• Validation
• Production Planning