Sr. General Manager Quality at Nitin Lifesciences-A Synokem Company (2025-04 – Present)
Responsible for Operational Excellence & Quality Operation of the Organization.
- Handling of all Technical Matters of the Organization.
- Operational Excellence and Operational and Capex Control.
- New Project Handling and Leading.
- First contact point for all customers for all technical matters.
- Technical Excellence & Smooth functioning of the plant.
- New product designing, assessment, and execution for products on P2P, Loan License and for export market.
- Responsible for Quality related activity of the organization.
- Implementation of Quality System in the organization.
- To make compliances for National & International Regulatory Agencies as per Current Guidelines like EU GMP, WHO & PIC/S.
- Organize need base GMP & GLP Training & Training as per requirement.
- Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System
- Documents Review & approval.
General Manager QA at Uni Medicolabs (2017-11 – Present)
Responsible for Technical & Quality Operation of all three Plants of the Organization, New Product Handling & Customer Dealing.
- Handling of all Technical Matters of the Organization.
- First contact point for all customers for all technical matters of all three sites.
- Technical Excellence & Smooth functioning of the plant.
- New product designing, assessment, and execution for products on P2P, Loan License and for export market.
- Coordinator for all new product projects.
- Manpower Reduction and Proper Utilization.
- Rejection Control and Yield Improvements.
- Process Optimization and Automation.
- Process Improvisation & Quality Improvement.
- Proper Machine Utilization with proper Planning.
- New business development.
- Planning and execution of new and crucial projects.
- Responsible for Quality, Regulatory, Technology Transfer and Rnd related activity of all three Units of the organization.
- Implementation of Quality System in all three Plants of the organization.
- To make compliances for National & International Regulatory Agencies as per Current Guidelines like EU GMP, WHO & PIC/S.
- Organize need base GMP & GLP Training & Training as per requirement.
- Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System
- Documents Review & approval.
Head QA at Rusan Pharma Limited (2015-01 – 2017-11)
Responsible for Technical & Quality Operation of the Plant.
- Handling of all Technical Matters of the Organization.
- First contact point for all customers for all technical matters of the site.
- Technical Excellence & Smooth functioning of the plant.
- New product designing, assessment, and execution for products for Domestic and for export market.
- Coordinator for all new product projects.
- Manpower Reduction and Proper Utilization.
- Rejection Control and Yield Improvements.
- Process Optimization and Automation.
- Process Improvisation & Quality Improvement.
- Proper Machine Utilization with proper Planning.
Head QA at Vivimed Labs Limited (2013-09 – 2015-01)
Responsible for QA, QC/RA & Technical & Quality Operation of the Plant.
- Handling of all Technical Matters of the Organization.
- First contact point for all customers for all technical matters of the Plant.
- Technical Excellence & Smooth functioning of the plant.
- Manpower Reduction and Proper Utilization.
- Rejection Control and Yield Improvements.
- Process Optimization and Automation.
- Process Improvisation & Quality Improvement.
- Proper Machine Utilization with proper Planning.
- New product design, assessment and execution for products on P2P, Loan License and for export market.
- Coordinator for all new product projects.
- To make compliances for National & International Regulatory Agencies as per Current Guidelines like WHO, D&C Act & ICH.
- Preparation & Up-dation of Documentation like SOP, STP, Validation & Qualification Protocols, Specifications Analytical Method Validation & various documents like Site Master File, Validation Master Plan, Quality Manual, Training Manual, Safety Manual & Product List etc.
- Setup Quality Management System in compliance with Domestic Requirements.
- To confirm and follow basic cGMP Norms in the Plant.
- To guide for Implementation of New Technology in Plant as per Current Regulatory Guidelines.
- To Provide Guidelines for Up-dation of Facility.
- To Conduct Plant Audit and Provide Guidelines for Better Improvement & Implementation of System.
- Preparation of Regulatory Audits and to organize Client Visits & Audits.
- Artwork Review & Approval.
- To assist & Monitor location QA in Compliance of various Audit discrepancies.
- Organize need base GMP Training & Training as per requirement.
- Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System.
- Documents Review & approval.
Asst. Manager Corporate Quality Assurance at Akums Drugs & Pharmaceuticals Ltd. (2009-06 – 2013-08)
- Planning and execution of new and crucial projects.
- Responsible for Quality, Regulatory, technology transfer and Rnd related activity of the organization.
- Implementation of Quality System in Plant.
- To make compliances for National & International Regulatory Agencies as per Current Guidelines like WHO, PICs, MCC, EU, MHRA & ANVISA.
- Preparation of Regulatory Audits.
- To assist & Monitor location QA in Compliance of various Audit discrepancies.
- Organize need base GMP & GLP Training & Training as per requirement.
- Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System.
- Handling of all Technical Matters of the Organization.
- First contact point for all customers for all technical matters of the Plant.
- Technical Excellence & Smooth functioning of the plant.
- Manpower Reduction and Proper Utilization.
- Rejection Control and Yield Improvements.
- Process Optimization and Automation.
- Process Improvisation & Quality Improvement.
- Proper Machine Utilization with proper Planning.
- New product design, assessment and execution for products on P2P, Loan License and for export market.
- Coordinator for all new product projects.
- To make compliances for National & International Regulatory Agencies as per Current Guidelines like WHO, D&C Act & ICH.
- Preparation & Up-dation of Documentation like SOP, STP, Validation & Qualification Protocols, Specifications & various QA related documents like Site Master File, Validation Master Plan, Quality Manual, Training Manual, Safety Manual & Product List etc.
- Setup Quality Management System in compliance with Domestic & Overseas requirements in 07 Plants of the Organization.
- To guide for Implementation of New Technology in all Plants as per Current Regulatory Guidelines.
- To Provide Guidelines for Up-dation of Facility.
- To Conduct Plant Audit and Provide Guidelines for Better Improvement & Implementation of System.
- Preparation of FDA & Regulatory Audits along with Location QA.
- Implementation of Common Quality System in all Seven Plants of the Organization.
Executive Quality Assurance at Shreya Life Sciences (2008-06 – 2009-06)
- Organizing Client Visits & Audits.
- To assist & Monitor location QA in Compliance of various Audit discrepancies.
- Quality System Documents for New Project.
- Organize need base GMP Training & Training as per Location requirement at all Plants.
- Participation in Technology Transfer activity, Gap Analysis and vendor audits.
- To ensure harmonization of Quality System & cGMP adherence in all Plants.
- Handling of Market Complaints, Deviations & Change Controls.
- Documents Review & approval.
- In charge of Oral Liquid & Lozenges Block.
- Management of Departmental Documents.
- IPQA, Qualification, Validation Activity in Liquid Oral Dosages Form.
- Preparation of Master Formula Record (MFR), Batch Manufacturing & Packing Record (BMR & BPR), Qualification Documents & Various Documents required for Quality System Implementation.
- Reviewing of BPCR.
- Maintenance of Critically Controlled Area and Working System for Quality Production.
- Co-ordination with QC, Production, Store, Packing to Produce Safe, Pure and Effective Quality Product.
- Preparation of WHO Required Documents.
Executive Quality Assurance at Alembic. Ltd. (2007-04 – 2008-06)
- Verification of Batch Sheet, BPCR, Process Validation Protocols & Reports and Product Release.
- Process Validation & Qualifications Activity.
- Responsible for In-Process checks during, Tablet, Liquid, Capsule Manufacturing & Packing.
- Management of Departmental Documents.
- Self-Inspection.
- Shop Floor Management.
- Calibration of In-process Quality Assurance Instruments.
- Maintenance of Critically Controlled Area and Working System for Quality Production.
- Co-ordination with QC, Production, Store, Packing to Produce Safe, Pure and Effective Quality Product.
- Preparing Daily Documents and Various Formats.
- Working allocation to the subordinate.
- IPQA Coordinator for Internal and External Audits.
- SAP related activity.
Trainee QA at Alkem Labs. Ltd (2006-06 – 2007-04)
- In-Process checks during DPI, Tablets, Capsules, Dry Syrup Manufacturing and Packing.
- Preparations of daily documents.
- Calibration of In-process Quality Control Instruments.
- Management of Departmental Documents &Annual Product Review.
- Management of Control Samples.
- Preparation and reviewing of BPCRs. & Process Validation.
- Organizing Client Visits & Audits.
- To assist & Monitor location QA in Compliance of various Audit discrepancies.
- Quality System Documents for New Project.
- Organize need base GMP Training & Training as per Location requirement at all Plants.
- Participation in Technology Transfer activity, Gap Analysis and vendor audits.
- To ensure harmonization of Quality System & cGMP adherence in all Plants.
- Handling of Market Complaints, Deviations & Change Controls.
- Documents Review & approval.
