1. RESUME
NAME : Joshi Satish Gopal.
ADDRESS : 84 - F, Lokamanya Nagar, T. H. Kataria Road,
Mahim, Mumbai 400 016.
TELEPHONE No.
MOBILE
: 022-4300684,
+919820852594
DATE OF BIRTH : 5th October, 1958
EDUCATION : B. Sc., Principal Subject – CHEMISTRY
April 1979, 55% Marks, Bombay University.
Correspondence Diploma in “Quality Assurance in
Pharmaceutical Industry”. Passed IRCA Approved ISO
9001:2015 & ISO 22000 Lead Auditor Exam.
WORK
EXPERIENCE
Total 35 Years.
16 Years in Pharmaceutical Industry
12 Years in Pharmaceutical & Agro Industry
4 Years in Agro Industry
18 months in Flavour Industry
18 months in Pharmaceutical Export Trading House
Personal Objective & Profile
I am a highly motivated professional in the area of Chemicals and API
manufacturing operations over the past 30 years.
I have worked with successful Pharmaceutical and Fine Chemical companies.
I was responsible as a Mid Management level Executive in Manufacturing
Operations under cGMP environment for export to developed countries. My
expertises are in Synthesis, Safety & Environment Controls and execution of
products.
I look forward to use my experience to be First / Second Party Auditor to
companies in these areas. Also would like to be a Third Party Auditor for ISO
Certification Bodies.
Or
I look forward to be a part of the QA Team in any Pharmaceutical / Chemical
Company.

2. Work Experience:
1)
ORGANISATION : GSK (Thane Factory)
PERIOD : January 1984 to December 1986
DESIGNATION : Skilled staff II in Production Department.
For two & half years I worked in GSK at Thane Factory in Betamethasone Plant
as Skilled Staff in Production Department where I was exposed to world class
cGMP and Safety norms and was trained to follow them in day to day
manufacturing activity.
2)
ORGANISATION : CIPLA LIMITED (Vikhroli Factory)
PERIOD : December 1986 to December 1995 ( 9 Years )
DESIGNATION : Production Head of Bulk Drug Plant.
JOB RESPONSIBILITIES AND NATURE OF WORK:
- I Joined Cipla as a Shift Production Officer & was subsequently promoted to
Production Head of API Division of Vikhroli Unit.
- Lead a team of about than 15 officers and 20 workmen who were reporting to
me as Production Head
- I was responsible for achieving production targets for export, local and captive
requirements, following strict cGMP and safety practices under USFDA
standards
- Contributed in preparation and was responsible for execution & maintenance
of Instrument Calibration & Equipment Preventive Maintenance Policies.
- Since Safety is of prime importance in any chemical industry, I participated
actively in safety initiatives like - Formulation of safety policy & emergency
procedures, Member of safety steering committee, Hazop study of the
reactions.
- Successfully implemented new products first on Pilot and, subsequently on
Production scale with sound technical transfer systems
- Have successfully faced Regulatory Audits (US FDA, MCA, South African,
WHO) and overseas Customer Audits as Production Head. I am well
conversant with the System & Documentation requirements of US FDA
related to API Manufacturing. (ICH Q7)
- Conversant with preparation of Batch Manufacturing Records, Annual Product
Quality Review, Product CTD (Manufacturing Sections), Site Master File, etc.

3. - As a part of continual improvement in Quality System, have conducted
Internal and intra unit cGMP Audits
- I was responsible for cGMP Training for API division reporting teams
- I had an exposure to basic cGMP requirements for Formulation ( Tablet &
Liquid Oral Manufacturing) at the same plant
3)
ORGANISATION : SEKHSARIA CHEMICALS LTD.
PERIOD : From January 1996 to November 1997 (about 2
Years)
DESIGNATION : Executive Quality Assurance
JOB RESPONSIBILITIES AND NATURE OF WORK:
- To enhance the knowledge I acquired in QA area in Cipla I joined Sekhsaria
Chemicals in QA Department. In Sekhsaria Chemicals I was responsible for
day to day Quality Assurance activities related to API manufacturing
- Responsible as a Team Member for Preparation, review & control of Master
Documents.
- I conducted training programs on cGMP, safety and operation of equipment
for manufacturing and engineering personnel
- Responsible as a Team Member for conducting validation exercises for unit
processes like cleaning, drying, blending, etc.
- Responsible for Internal Audit Management
- Responsible for Complaint investigation and Corrective / Preventive Actions
management (CAPA)
- I was authorized person for release of finished product for sale.
4)
ORGANISATION : HIKAL LIMITED, TALOJA
PERIOD : November 1997 to October 2007. ( 10 Years)
DESIGNATION : AGM, Quality Assurance
JOB RESPONSIBILITIES AND NATURE OF WORK:
- Initially for first three years I worked with Merck USA Quality Assurance
Team. During this period I had been to Merck USA for two weeks to
understand the Quality Assurance systems & procedures followed at Merck
USA
- Established Quality Assurance systems throughout the plant as per the norms
of Merck USA and helped the unit to qualify for Local Release Authority
- Was responsible for day to day Quality Control & Quality Assurance activates

4. - I was authorized for release of Finished Product
- As routine QA activities I was responsible for Training Coordination and
execution throughout plant, Internal Audit Management, Complaint
investigation and management, Finished Product Label Control Management,
etc.
- I was responsible for Vendor Qualification Management
- I was given responsibility to help other Hikal units to formulate & establish
Quality Assurance system.
- I was deputed to Hikal Bangalore API Plant to help in establishing QA system.
Prepared documents like Validation Master Plan, Design, Installation,
Operation & Performance Qualification documents, departmental SOPs’, etc.
- Was a team member for Australian Drug authority audit
- As a Management Representative of ISO14000 & OHSAS 18000
successfully completed one surveillance and one re-certification audits each
- As a Management Representative of ISO 17025 (Certification for Testing
Laboratories) successfully implemented the Quality System requirements and
completed the certification process
5)
ORGANISATION : RALLIS INDIA LIMITED
PERIOD : October 2007 to April 2012 (about 5 Years)
DESIGNATION : DGM, Quality Assurance
JOB RESPONSIBILITIES AND NATURE OF WORK:
- I Worked in Corporate Quality Assurance Department
- Overall Responsible for implementing Quality Assurance system required for
ISO 170025 in Quality Control Laboratories of four manufacturing units of
Rallis. All laboratories got ISO 170025 Certification in record time of 18
months
- Rallis was using services of Third Party Formulators to meet production
targets. I was responsible for Devising & implementing systems for
Qualification of a Third Party Formulator. This helped in reduction of number
of complaints over the years. Conducted Quality Audits of Third Party
Formulators.
- Prepared Formulation Manuals so that the product transfer from one unit to
other becomes seamless and without initial operational errors
- Reviewed and rationalized the Finished Goods Specifications so that they
comply with regulatory, customer and internal requirements
- Since Rallis was having a large number of Agro Formulations, control on
printed material was an important activity. I Implemented Printed Material
Control management system effectively

5. - I introduced formal Customer Complaint Management system which resulted
into reduction in number of complaints over the years through process
mapping
- Established Vendor Management System and conducted Vendor Quality
Audits with proper rating system
6)
ORGANISATION : S. H. KELKAR (Flavour Division)
PERIOD : April 2012 to January 2014 (about 2 Years)
DESIGNATION : Head Quality Assurance
JOB RESPONSIBILITIES AND NATURE OF WORK:
- Worked in Quality Assurance Department. Overall Responsible for
implementing Quality Assurance system required for Food safety standards
- I was given an additional responsibility of establishing and managing day to
day Quality Control Laboratory activities
- I was responsible for implementing Food Safety Systems and obtaining
certification for Food Safety System (FSSC 22000)
- Established Vendor Management System and conducted Vendor Quality
Audits
- Established Customer Complaint Management system in line with Pharma
7)
ORGANISATION : OCEANIC PHARMACHEM Trading and Export
PERIOD : January 2014 to August 2015 (about One & Half
Years)
DESIGNATION : Manager – Quality Assurance
JOB RESPONSIBILITIES AND NATURE OF WORK:
- Established Quality Management Systems as per ISO 9001 and ISO 22000
(Food Safety Management) requirements for an Export Trading Company
- Responsible for liaison between Overseas Customer and Indian Manufacturer
for Quality related issues
- Checking and Verification of Overseas registration and Audit compliance
documents prepared by Indian Manufacturers and correcting them as
needed. This helped in reducing the time as well number of communications.
- Helped in overseas recertification of four Indian Manufacturers
- Responsible for Customer Audit Coordination from Planning, Logistics, Pre –
Audit Documentation to successful Audit Compliance

6. - Participated in quality audits of Indian Manufacturers along with Overseas
Customer to facilitate registrations and starting of export
Reference:
Dr. S. Ramanathan, Bangalore
Ex. VP
Hikal Limited
Mobile: +919916920255
Mr. S. G. Belapure
Ex – Factory Manager
Cipla Limited, Vokhroli Factory
Mobile: +919974051999
Dr. V. B. Malkar
Ex – VP QA
Sekhsaria Limited
Mobile: +919967532520