Educational Qualifications:
M. Sc. (Bio-Chemistry)

Summary of Professional Experience: Total Experience: 31 Years
1.Experience in Quality Control and Quality Assurance functions
2.Experience in designing and layout of manufacturing plant and laboratory with GMP requirements.
3.Experience in auditing manufacturing facilities of formulations and Bulk Drugs, Chemical and Microbiological Laboratories and R&D facilities.
4.Technology Transfer for Drug Products and Medical Device from various International customers and MNCs. Interaction with these customers on an ongoing business.
5.Experience in training on GMP, ICH, Regulatory, and Manufacturing & Laboratory controls, Technology Transfer, Good Contamination Control Practices, Media Fill and Aseptic Processing.
6.Conducting and participating in outside technical training programs as a speaker.

Special Projects:
1.Conducting training of more than 2000 employees on Developing Quality Culture of Compliance.
2.Preparing manufacturing sites of client companies for regulatory audit from ANVISA, TGA, USFDA,WHO, MHRA, etc.
3.Designing and helping clients on Remediation plan for Audit observations.
4.Training and educating pharmaceutical organizations/personnel to prevent issues related to data integrity, data reliability and data accuracy.
5.Engaged in developing good behavior and habits in pharmaceutical manufacturing.

Current Status:
Working to usher in a novel concept of GMP & Regulatory training & education.
Main Contributions:
1.Facility & Laboratory design and Layout: Successfully designed, commissioned, and qualified several facilities (11 oral solid dosage facilities, 15 injection facilities, and 8 API facilities).
2.Providing solutions: to several pharmaceutical professionals/organizations on Policies / Procedures, cGMPs, Remediation Plans, Risk based approach, PAT, Aseptic processing, GMPs for sterile medicinal products, Laboratory Controls & Compliance, Validations, Microbiological Practices, process simulation/media fill study, 21 CFR Part 11 and GAMP.
3.Experienced Auditor: Conducted several third party audits and GAP analysis of R&D, Manufacturing facilities (APIs, Dosage Forms, & Medical devices), and QC Laboratories (Chemical, Microbiological and Clinical).
4.Document Reviews: Reviewed several key documents for clients such as, SMFs, VMPs, Validation protocols & Reports, Analytical Data, Bio-equivalence study protocols and reports, ANDAs and DMFs and their responses.
5.GMP Trainer: Conducted more than 120 training sessions on GMPs, Regulatory, Validations, Microbiology, Aseptic processing, ICH guidelines, US & European guidelines, manufacturing & Laboratory technologies.

6.Other Contributions:
Successfully led teams to obtain Regulatory approvals for companies where employed as well as for current client companies.
Successfully developed robust GMP systems in more than twenty companies (Client companies included)
Technology Transfer for Drug Products and Medical Device from International customers.

Career Profile:
Started my career in Pharmaceutical Formulations with Lupin Laboratories at Aurangabad.
During this tenure I had worked in various sections of Quality Control Lab. and Quality Assurance functions. While working I have gained hands on experience in chemical, Instrumentation and microbiological analysis of Raw Materials, Intermediates, Finished Products and sampling of RMs (Sterile and non-sterile), FPs.

Specific area of work:
a)Microbiological and Biological testing
b)Validations (HVAC, equipment, critical utilities, water system and sterility test).
c)Significant contribution in preparation and execution of Validation Protocols.

Wockhardt Ltd. as Manager - Quality Assurance for its Parentral Division in Aurangabad.

Responsibilities
1.Responsible for Quality Assurance functions and activities for Parenteral Preparations unit.
2.Lead the manufacturing site for various regulatory audits.
3.Specific area of work was in preparation of Registration dossiers for CIS countries, African and Far East Countries.
4.Was a lead auditor for ISO and GMP audits
5.Assisted other locations of the company for preparation and facing various Regulatory audits of US FDA, MCA, and TGA.
6.Played a pivotal role in Business Transfer with respect to Quality System from Wockhardt to Baxter.

Achievements
a)Certified Lead Auditor for ISO
b)Assisted in preparation and facing the various Regulatory audits of US FDA, MCA, TGA, and IDA-Hungary.

Baxter India as Manager – Quality Assurance for its acquired facility in Aurangabad.
Responsibilities
1.Responsible for Quality Assurance functions and activities for Parenteral Preparations.
2.To harmonize the Quality system as per corporate guidelines.

Achievements
a)Developed Quality Standards in alignment with Baxter Corporate Quality Standards by integrating the Quality Policies, Manuals, Practices and Procedures.

Lupin Pharmaceuticals as Sr. Manager - Quality Assurance for its Formulation Plant I & II at Mandideep and Goa
Responsibilities
1.Responsible for Quality Assurance functions and activities for Formulation Plants I & II of Mandideep Location
2.Responsible for setting up QC Laboratory and Quality System of new facility at Goa.
3.Ensure efficient and effective management of Regulatory Compliance, Audits, QA/QC Documentation, Validation and Training functions.

Achievements
a)Developed Quality System in new Goa – facility (Solid Orals) in a short span of 8 months.
b)Successful Regulatory inspections from MHRA, US FDA, INVIMA (Columbia), and several customer (MNCs) audits.
c)Successful execution of 21 ANDA products and submission of dossiers from new facility.
d)Provided training for GMP, ICH Guidelines, Regulatory Guidance, SOPs, Validations, Tech Transfer.

Nicholas Piramal India Ltd. Pithampur (now Piramal Healthcare Ltd.) as General Manager - Quality Assurance
Responsibilities
1.Shared responsibility in Business Development and Business Continuity through Quality Assurance in manufacturing and services to customers.
2.To provide leadership and effectively lead the QA Team
3.Define and implement a perpetual policy plan of QA standards.
4.Ensure effective implementation of Quality Policy.
5.Developing QA and QC function to meet international regulatory requirements.
6.Ensure efficient and effective management of Regulatory Compliance, Audits, QA Documentation, Validation and Training functions.
7.Evaluation and Competence Mapping for employees at different levels in the Manufacturing Plant and prepare Competence building program for employees.
8.Responsible as a core team member for Harmonizing Quality System across the organization. In view of this I have undertaken several Training sessions on GMP, technology Transfer, Documentation, and Auditing.
9.Lead coordinator for regulatory inspections of IMB, SA MCC, MHRA & US FDA.
10.Prepare remediation plans and suitable answer to audits/queries from Regulatory authorities.
11.Implement corrective measures based on Rejection analysis, Market complaint analysis and Quality audits,

Achievements
a)Developed quality systems to meet the international standards
b)Led the company in various routine and potential Customer Audits and several regulatory inspections successfully and securing approvals from IMB, MHRA, SA MCC, INVIMA., USFDA
c)Provided training on various GMP topics covering ICH, Regulatory Guidance, Microbiology and chromatographic practices.

Spearheaded the organization for USFDA, MHRA and other Regulatory Inspections and got several Product Approvals.

Famy Care Ltd. as Vice President - CQA/QC
Responsibilities:
1.Sharing responsibility in Business Development and Business Continuity through Quality Assurance in manufacturing and services to customers.
2.To provide leadership and effectively lead the Quality Unit
3.Define and implement a perpetual policy plan of QA standards.
4.Develop and harmonize systems and practices across different locations of the organization.
5.Evaluation and competence mapping for employees at various levels in the Manufacturing Plants and prepare competence building program for employees.
6.Develop corporate policies for GMP
7.Preparing manufacturing sites to be all time ready for Regulatory Inspections
8.Auditing of API Vendors
9.Spearheading the regulatory inspections
10.The Site had manufacturing of Hormones as sterile Injections and Tablet dosage forms.

Achievements:
a)Approvals of hormone products by EU, Health Canada, US FDA, ANVISA, WHO and other regulatory agencies.
b)US FDA for 32 ANDAs of two manufacturing sites. The inspection was for 45 man-days by three inspectors.

Sr. Vice President – Operations in Aurobindo Pharma. (Subsidiary Joint Venture companies Auronext and Eugia Pharma Specialties).
1.The responsibility is to steer and control joint venture companies for its:
2.Administration and Governance - organization of people, facility, policies, contracts, legal and statutory compliance. This also includes coordination with joint ventures partners.
3.Finance and Accounts - Provide and control funds for capital and expense, product costing. Improving and presenting Balance sheet to the Board members.
4.Business Development - Manufacturing contracts with customers
5.Technical Aspects - Manufacturing, technology transfer, regulatory filings, regulatory approvals.

Guiding and control on Process Improvisation and optimization for Sterile API and Formulations.
Achievements:
1.Approvals of Penem products by MHRA and US FDA and Hormone & Cytotoxic products by EU.

Sr. Vice President CQA (India & US) – Mankind Pharma Ltd.
1.Responsible for overall corporate quality assurance in Mankind owned manufacturing facilities and all associate companies.
2.Leading corporate role for harmonizing systems and documentation across the organization.
3.Partnering for steering the Project of launching products in US Market.
4.Responsible for GMP-Due Diligence for acquisitions.
5.Setting up systems and documentation for new facilities (OSD & Injectable) and preparing for the sites for regulatory inspections.

Organized and delivered seminars in several conferences:
a)“How to be an Effective GMP Auditor” on 4-5, Apr 2008 at Indore.
b)“Conference-cum-Workshop: Validation Week” on 10-14, Jun 2008 at Chandigarh.
c)“Aseptic Processing & Regulatory Documentation” on 25-26 Aug 2008 at Goa.
d)“Competency Development in GMPs & Regulatory Compliance” on 17-18 Apr 2009 at Pune.
e)“Current Trends in Aseptic Processing – A Risk Based Approach” on 26-27 Jun 2009 at Indore.
f)“Good Engineering Practices in Support of Pharmaceutical Manufacturing” on 13-14 Nov 2009 at Hyderabad.
g)“Handling of Deviations and CAPA” on 23 Dec 2009 at PIGMP Training Center, Dehradun.
h)“Workshop: Validation Week” on 2-6 Feb 2010 at Aurangabad.
i)“Process Validation & Product Quality Review” on 8th Mar 2010 at Chandigarh.
j)“Current Trends in Stability Studies” on 26th Mar 2010 at PIGMP Training Center, Dehradun.
k)“Change Control & OOS” on 8th Apr 2010 at Chandigarh.
l)“Developing Competency in GMPs & Regulatory Compliance” on 13-14 May 2010 at Hyderabad.
m)“Internal Audits & Training” on 8th Dec 2017 at Conference on ‘Shifting form Schedule M to WHO’ organized by Indian Drug Manufacturers Association.