Yatesh Parmar

With 15+ years of diverse professional experience, including over 9+ years exclusively in Quality Assurance, an accomplished Officer Quality offers a proven track record in ensuring operational excellence, compliance, and quality leadership across pharmaceutical and medical device industries. Currently positioned at Microtrol Sterilisation Pvt. Ltd, Bawal as 'Officer Quality' since July 2016 driving sterilization processes for critical pharmaceutical excipients, medical devices, and herbal products.

Responsible for GMP, ISO 13485, ISO 9001 and USFDA compliance, overseeing key processes such as validation studies, equipment qualification (IQ, OQ, PQ), CAPA management, sterility analysing, and process validation. Skilled in managing IPQA activities, supplier quality audits, risk assessments, and implementing SOPs and contamination control strategies. A dedicated professional focused solely on Quality Assurance, leveraging technical expertise, continuous improvement strategies, and effective documentation to ensure compliance, streamline processes, and maintain the highest quality standards in every operational step.

Officer Quality - Microtrol Sterilisation Pvt. Ltd - Bawal

(2016-07)

Driving sterilization processes for critical pharmaceutical excipients, medical devices, and herbal products. Responsible for GMP, ISO 13485, ISO 9001 and USFDA compliance, overseeing key processes such as validation studies, equipment qualification (IQ, OQ, PQ), CAPA management, sterility analysing, and process validation.

• Assist Corporate Quality Assurance Manager for developing & implementing QMS in the facility.
• Day to day routine correspondence, Document control, active involvement to implement the system in-place.
• System set-up: Quality system development (procedures, work instructions, specifications, formats).
• Set-up performance standards of incoming, inprocess & finished product stage.
• Customer Complaint Handling: Categorize the problem (genuine or non-genuine), response to the customer, analysis (root-cause analysis), Training and C&P action.
• Audits: Conducting Internal Quality Audits (categorize the NC's preparation & circulation of report, logging the NC's for further action.
• Close-out NC in the system on verification of effectiveness of the CAPA, active support in ISO & Corporate Audits also responsible for supplier audits.
• Sampling: Managing sampling of products & ensuring proper line clearance.
• Facility Cleanliness: Monitor cleanliness and verify equipment cleaning records as per SOPs.
• Ensuring proper handling of QMS activities like Training, GMP, GDP, Housekeeping, CAPA & Change Control, Internal Audit Documentation, BMR & Deviation related reports.
• Responsible for the shipment of material for export after Sterilisation.
• Training & development, Key operating measures (Quality, Production)
• Implementation of ISO9001:2015 & ISO13485:2016.
• Communication with suppliers and customers QA representatives.
• Responsible for handling non-conforming products & customer satisfaction feedback.
• Approval authority for QA & QC SOP's & listed in Approved Internal Auditor of facility.
• Handling customer Audits, Certification audits and regulatory audits.
• Follow up of CAPA and Appraisal of trainings provided.
• Lead audits for prominent organizations, including GlaxoSmithKline, Becton Dickinson, Hollister Medical India, Polymedicure, Himalaya Wellness and Advance Microdevices Pvt Ltd.
• Operating various instruments, including BOD incubators, Autoclave, spectrophotometers & EPR (Electro Paramagnetic Resonance).

Hema Engineering Industries Ltd - Gurgaon

(2014-01 - 2015-11)

HPL Group 'in' HPL Electric & Power Pvt Ltd - Gurgaon

(2011-01 - 2013-09)

Microtrol Sterilization Services Pvt Ltd

(2007-11 - 2010-06)

P.G Diploma - Materials Management - Annamalai University

MBA - Human Resources Management - M.D.U Rohtak

B.Sc. - Non-Medical - MDU Rohtak

Intermediate - Non-Medical - BSEH Haryana

Matriculation - CBSE New Delhi