Shailesh Krishna Patil

Total 20+ years of experience working with reputed organizations in the Pharmaceuticals (API & Formulation)/Medical Device /FMCG/Chemicals industry.

Medical Device

.Quality Assurance & Regulatory affairs Manager in the Medical Device Field for the last 5 +years.

.Experience with management and implementation for the ISO 13485, ISO 9001, and 21 CFR Part 820 standards in relation to medical devices.

Assisted in getting multiple devices 510(k) certified with the FDA. .Oversaw training employees on Standard Operating Procedures & Regulatory standards kept detailed logs of such training.

.Ensured constant compliance to all QMS activities.

.Directly responsible for customer complaint resolution, CAPA's and all product recall activities.

.Built Product Specification Documents, and revised Formulation Specifications for multiple medical devices.

.Reported directly to the CEO/Director and worked in conjunction with the production supervisor to ensure the highest level of compliance and productivity on the production line.

.Lead Quality Control/Quality Assurance & Regulatory affairs related operations.

.Preparation and review of Quality Agreement of contract Manufacturing unit of loan license, P-to-P and in licensing units.

.Audit/Review and qualification of new/proposed contract manufacturing units for Medical Devices and combination product by supporting the auditing/scrutinizing compliance to ensure that the right unit is approved.

.Manufacturing License activity for Class-A,B,C devices, Free sale certificate,Neutral code certificate,Sales and distribution license, cGMP certificate, Technical staff approval project by coordinating state FDA and CDSCO.

.Preparation and review of Design and Development file and Device Master File.

Pharmaceuticals – Quality Assurance and Regulatory

· Experienced Quality Assurance and Regulatory affairs manager with 7+ years in the pharmaceutic Industry.

· Proven track record in developing and managing regulatory strategies and handling regulatory submission.

· Successfully developed and implemented regulatory strategies for new and existing products to ensure compliance with FDA and international regulations.

· Collaborated and maintained effective communication with the FDA, Notified bodies and other regulatory agencies.

· Result oriented Quality Assurance Manager ensuring compliance with quality standard and driving continuous improvement across manufacturing and pharmaceutical industries.

· Skill in leading cross functional teams, implementing robust quality management system and resolving complex quality issues.

· Proven track record of achieving significant improvement in product quality, customer satisfaction and defect reduction.

· Passionate about driving excellence through a customer centric approach and fostering a culture of continuous improvement.

Pharmaceuticals – Production

· Experienced in production in the pharmaceutic Industry.

· Highly developed skills in operations. Adept daily upstream operation in cGMP manufacturing environment.

· Goal oriented disciplined professional with over 2.5+years of experience with a commitment to comply regulatory requirement.

FMCG/Chemical – Production & Quality Control

· 5 + years of experience as a Production chemist and Junior officer production in Food dyes manufacturing industry and Specialty chemicals industry.

· 4+ Months of experience as a trainee QC Chemist in Pigment manufacturing Industry.

Timely completion of Health authority inspections and audit compliances.
Successfully handled projects for availing manufacturing licenses for various Devices like Nebulizer, Digital
Thermometer, Blood Pressure Monitor, Hand Sanitizing Wipes, IVD kits, Spirometer, Dry Powder Inhalers,
Immunofluorescence Analyzers, IVD’s etc.
Successfully handled license activity for - Free Sale Certificate, Neutral Code Certificate, Sales and
Distribution License, GMP Certificate, Technical Staff Approval project by coordination with State FDA &
CDSCO.
Coordination of project to implement the MDR 2017/745 (MDD to MDR Transaction)
Timely implementation of the recent guidelines like Medical Device Rule -2017, Medical Device Regulation
(CE) for Europe & upgrade Quality Management system accordingly. Reduction in lead time for the technical
responses and compliances to the global customers.
Successfully handled MHRA inspections in 2018 without critical observations at Flamingo Pharmaceuticals.
Successfully handled USFDA inspections in 2014 at Sandoz (Novartis) Pvt Ltd. & in 2019 at Phoenix
Innovative Healthcare Manufacturers Pvt Ltd without critical observations.
Successfully handled CE (Europe), ISO 9001:2015, ISO 13485:2016 inspections in 2019 at Phoenix Innovative
Healthcare Manufacturers Pvt Ltd without critical observations.
Providing trainings and guidance to teams for promoting a quality awareness & enhancing compliance

Date of Birth: 18 May. 1983 

Industry Preference: Medical Device/Pharmaceutical/Healthcare/FMCG

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