Nandkumar Chavan Email & Phone Number

• Ensure the activities cGMP and GLP compliance in all departments of both the plants Beta lactam and Non-beta lactam.• Ensuring environmental monitoring of manufacturing area and Plant hygiene is within the requirement.• To face the audit and responsible to comply the observations and to send the CAPA report. • Imparting various Quality Management System related training such as CGMP, GDP, CAPA, QRM, OOS, and Incidents etc.• Review of executed Batch Manufacturing Records/Batch Packing Records.• Approval of SOPs of QA and all other departments.• To provide required data / documents to regulatory department. • Review of Master and Executed Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Process Validation (PV), Instrument Qualification, System Qualification, Cleaning Validation (CV), Analytical Method Validation (AMV), Facility Validation and Computer System Validation (CSV).• Ensure proper retention of GMP records.• Handling of change control, deviation, market complaints, Internal audits, Out Of Specification, Out of Calibration, Quality Risk Management record, market recall and CAPA.• Evaluation & approval of vendors frequently based on trend analysis.• Planning for the execution of various validation activities such as Process Validation, Cleaning Validation, Equipment Validation, Facility Validation, PLC/Computer system validation in co-ordination with concerned department and contracted external agency.• Review of artworks and proofing for printed packaging materials for customer, regulatory and marketing compliance.• To ensure the cross functional activities with other departments.• To conduct a Product Development Meeting as a Chairman.

Listed skills include Gmp, Validation, Quality System, Standard Operating Procedure, and 15 others.