AGM Production - Cadila Pharmaceuticals Ltd. - GIDC-Ankleshwar-Gujarat-State
(2025-02)
Sr. Manager Production - Ipca Laboratories Ltd. - MIDC-Mahad-Maharastra-State
(2017-03 - 2025-02)
Manager Production - Divi's Laboratories Ltd. - Chippada village, Visakhapatnam, Andhra Pradesh
(2014-01 - 2017-02)
Executive- Production - Bajaj Heath Care Ltd. - Savli- Vadodara-GIDC, Gujarat
(2010-05 - 2013-12)
Officer Production - Aarti Drugs Ltd. - MIDC- Tarapur-Boisar Maharashtra State
(2007-03 - 2010-04)
- Responsible for Managing the operations of the manufacturing plant, such as Meeting the Production targets, Technology Transfer, Capacity enhancement, Trouble Shooting, Process and General safety
- Handling OOS, OOT investigation, CAPA to comply Regulatory requirements such as USFDA, TGA, WHO, EDQM, Quality Compliance (cGMP) by QRM & QBD
- Maintaining production plants, Documents with cGMP compliance for Regulatory Audits and EHS Audits
- Handling 85 Kl volume with 110-man power handling
- Tracking of Quality and yield with CPP to maintain yield with quality on daily basis
- Conducting Training to the Team on cGMP Compliance and Process Safety, Process development & optimization
- To lead the PD Lab for smoothly Technology Transfer by Absorbing the Technology from R&D and Transferring to the Manufacturing plant to Scale-up & validate the process at the Manufacturing Plants with adding extra CPP by closly monitoring to achieve yield with quality and safety
- Led the Production team to achieve complies Audits of EDQM, WHO, KFDA, & Oversees and domestics customers
- Continuous improvement by Solvent recovery, Yield improvement/Optimizing consumption coefficient, Capacity enhancement- De Bottlenecking, Troubleshooting with PD lab
- Project engineering/ Technical services to provide the support for Technical requirement- URS, Payback period, DQ, IQ, PQ
- Conducted internal Training on cGMP/ALCOA Principle/Audit Facing/Validation/GOAL achieving/productivity increasing with Team work/Delegation of work, Etc... to the Production Team
- Project management/Outsourcing job work- Complete Management from capacity calculation, facility evaluation in purview of QC, Production, Utilities, Quality Management system to complete the Project successfully
- Led the Production team to clear USFDA, WHO and Domestic Customers Audits with Zero Observation year February 2020
- Prospective Validations of the 4 New products has been done
- Scaled up & done Concurrent Validations of 4 Perennial Products to meet the Production Order across for the 2 Manufacturing Sites
- Conducting Tech -Transfer meetings with R&D HOD'S (Product's owner)
- Having exposure on manufacturing of API & Bulk drugs products, new products handling, scale up of products
- Process mapping, Process Validation, Cleaning Validation, handling of different equipment's used in Production
- Possessing key skills and competencies in Strategizing production and operational activities, streamlining operations for cost optimization, maximum resource optimization and reducing batch cycle time through close monitoring of unit operation and equipment debottlenecking
- Planning and thorough implementation of Quality product manufacturing
- Discussing about the process & critical process parameters based on the provided Tech-Pack, thus absorbing the Technology from R&D and Transferring to the Manufacturing plant to achieve the Desired Quality and Expected yield with Safety aspects
- Delivering the Required Quantity as per the timeline committed to the customers
- To scale up & modify the process at Kilo lab scale by optimizing the process Parameters and considering cost, environmental & safety aspects
- Equipment selection as per process criticality and their compatibility with chemicals involved in the reactions with optimum batch size
- Planning and coordination with maintenance and safety departments for carrying out Hazop study of the process, & Production, stores, QA. & QC dept. during the batch execution
- Enhanced the production Capacity of more than one Product about 12.5 Ton /Year
- Totally involved in all QMS Activity with ALCOA and ALCOA+
- Co-ordinate with R&D department regarding tech transfer, transferring product from PD Lab Scale to Commercial scale up to validate the product, during commercial Mfg. taking help to reducing cost/effluent and improved in yield
- Sometimes taking help to find out Root Cause in QMS Activity
- Motivating the Teams & training them periodically on the product & process changes
- Creates new and different ways of doing things for competitive advantage
