Amit Sharma

Senior Quality Control and Quality Management Systems professional with 25+ years of experience across Medical Devices, Pharmaceutical Manufacturing, Government Laboratory Systems, and Regulated Healthcare Industries. Expert in implementing and managing ISO 13485:2016 Medical Device Quality Management Systems, ISO/IEC 17025 Laboratory Quality Systems, and global regulatory compliance frameworks. Proven leadership in quality control operations, supplier qualification, regulatory audits, CAPA systems, validation programs, and multi-site laboratory quality management.

Extensive experience supporting international regulatory inspections including USFDA, EU-GMP, MHRA, WHO-GMP, and other global regulators.

Head – Quality & Management Representative - Moditech International - Mohali, Punjab

(2024-09)

Leading quality control operations and QMS implementation for a Class B non-sterile medical device manufacturing facility.

• Implement and maintain ISO 13485:2016 compliant Quality Management System.
• Lead quality control testing for raw materials, in-process products and finished medical devices.
• Manage supplier qualification and subcontractor audits.
• Conduct internal audits and regulatory audit preparation.
• Ensure CDSCO regulatory compliance and documentation control.
• Implement CAPA, deviation and change control systems.
• Support new product development (NPD) and design quality activities.
• Manage testing equipment calibration and validation systems.
• Maintain quality records, non-conformance reports, and regulatory documentation.

Chief Chemist – Punjab State Laboratory Quality Systems - Department of Water Supply & Sanitation, Government of Punjab

(2020-06 - 2024-08)

Headed 33 stationary laboratories and 06 mobile laboratories operating under JJM funding, ISO/IEC 17025 NABL accreditation.

• Implemented ISO/IEC 17025 quality systems across state laboratory network.
• Led NABL accreditation and surveillance audits.
• Developed SOPs, validation protocols, and laboratory quality documentation.
• Oversaw analytical testing using ICP-MS, AAS, Ion Chromatography, BOD, COD, microbiological systems.
• Implemented LIMS and water quality monitoring systems.
• Led training programs on GLP, GDP, and laboratory quality compliance.

Sr. General Manager – Plant Head & Site Quality Compliance - SGS Pharmaceuticals Pvt Ltd

(2012-02 - 2020-06)

Led corporate QA/QC operations for WHO-GMP pharmaceutical manufacturing facilities supplying regulated international markets.

• Headed QA, QC, stability studies and formulation development quality systems.
• Managed quality teams and cross-functional manufacturing operations.
• Implemented validation programs and analytical method validation.
• Conducted vendor qualification and contract manufacturing audits.
• Prepared facilities for global regulatory inspections.

Sr. Manager – Quality Assurance - Ranbaxy Laboratories Ltd.

(2002-06 - 2009-06)

Managed quality control laboratory operations in USFDA / EU-GMP regulated manufacturing facilities.

• Analytical testing and QC laboratory management
• OOS / OOT investigation and CAPA implementation
• Method transfer and validation
• Regulatory inspection preparation
• Training of QC analysts

Sr. Manager QA/QC - Alkem Laboratories Ltd

Sr. Executive QA/QC - Saboo Berlac Ltd

Production Associate - ICI Paints

Approved Chemist - Honey Bee Natural Products

M.Sc. - Analytical Chemistry (Specialization in Commercial Methods of Chemical Analysis) - Gurukula Kangri Vishwavidyalaya, Haridwar

B.Sc. (Honors) - Chemistry, Physics, Mathematics - Gurukula Kangri Vishwavidyalaya, Haridwar