Page 1 of 3

CURRICULUM VITAE
Atul Nagnath Gaikwad (AM- Corporate Quality)
C-204 GK Royal Hills, Ravet, Pune
Mob. +91-8329944793; 9689690574.
E-mail: atul_pharma2007@rediffmail.com
Total Work Experiance : 9 years 6 months.

CAREER OBJECTIVES:

To achieve excellence in working as dynamic professional offering solutions to business using the best
available where my ability and analyzing quest are used maximum for growth of the organization and to
grow with the organization. Seeking a challenging position in well established company that offers
professional growth and ample opportunity to learn and enrich my competencies in my profession.

PRESENT OCCUPATION:
Presently working with M/s Emcure Pharmaceutical Ltd., Pune
Designation:Asst. Manager-Corporate Quality (QMS+internal Audit+Hormonization of SOP)
From: July 2017 to till date.
Job Responsibilities:
 Responsible for handling of Quality management system Change control, Deviation, and CAPA
related Process and Quality.
 Responsible for Investigation/Impact assessment changes related to Quality, Process, , Product,
Documents, Equipments and software/ Computerised system.
 Responsible for perform internal audit and compliance rounds.
 Resposible for review of qualification related to computerized sytem in production as per GAMP 5.
 Review, Preparation and implantation of Hormonized of SOPs as per regulatory Guidance.

PAST EXPERIENCE:
1. M/S. MICRO LABS Ltd Goa and Banglore.
Worked as Asssistant Manager- Quality Assurance and Development QA with Microlab ltd.
From JULY 2012 to July 2017.
Job Responsibilities:
Quality Management System Review
 Review and assessment of Change control, Deviation, and CAPA and closure after the successful
completion of related activities & effectiveness check.
 Preparing and conducting quality system review.
 co-ordianate internal audit as per six system Approch.
 Investigation/Impact assessment changes related to Quality, Process, Product, Documents,
Equipments and software/ Computerised system.
 Review and assessment of vendor documents.
 Review of Manufacturing Documents & Analytical Document like BMR,BPR,RM & FP
Speicification.
 Review of Instrument/Equipment, software Qualification documents.
 Review, Preparation and implantation of of SOPs as per regulatory Guidance.
 Page 2 of 3
Development Quality Assurance:
 Preparation and review of Manufacturing documents related to Process Optimization, Exhibit and
validation batches for regulated market.
 Co-ordination planning and Execution of Demonstration / process Optimization Exhibit and
validation batches.
 Co-ordination with stakeholder like FR&D,site Tech.Transfer and Site QA day to day execution of
activities.
 Preparation of Master BMR and BPR for the Pre-Exhibit and Exhibit batches.
 Review of filled BMR & BPR of Pre-Exhibit and Exhibit batches.
 Active involvement to reduce Deviation and quality problem.
 Investigation of Lab events, proposed changes and R & D documents.
 Review of Technology Transfer Documents like MFR ,MPR, PDRF and BOM etc.
 Review of the Continues Process Validation and CPPQ for regulated Market.
 Preparation and review of Intended commercial documents for the regulatory market.
 Review of Stability study protocol and report for Regulated Markets.
 Review of Cleaning validation Protocol and Report with New molecules.

 Audit Faced: MHRA & WHO, Health CANADA and USFDA

 Customer Audits :Teva, Mylan, BBUK, Sanofi and Biogaran.
---------------------------------------------------------------------------------------------------------------------------
2. M/S. Cipla Ltd. Goa.
Duration: August-2007 to June-2008 & July-2010 to June-2012 ( 2 Year 11 Months)
Designation : Production Officer (OSD)
Job Responsibilities -
 To develop, implement and maintain quality standards and systems to ensure that products comply
with Marketing Authorizations, specifications and cGMP.
 Validation of process periodically.
 Personal supervision in Tablet, (Granulation/Compression/Coating Department)
 Online troubleshoot of problems in Tablet, Granulation and Compression Department.
 Online maintaining of BMR/ BPR as well as all necessary documents as per Regulatory Authorities.
 To review and approve BMR& BPR within agreed timelines.
 Active involvement to reduce Deviation & quality problem and Release/ rejection of products.
 Preparing the Master documents as per the Market Requirement & Product History Files.
 Preparation of Qualification of Compression Machine/ Inprocess checks Intrument and necessary
documents.
 In process quality control checks in Granulation & Compression department.
 Production planning & Manpower handling and target achievement.
 Handling of Change control & Planned and Unplanned Deviations releted to Equipments and
process in Production Department.

 Faced Audit: TGA, USFDA, WHO, ANVISA.

 Page 3 of 3
Educational Qualification:
Sr.No. Exam Passed School / college University Class/Year

1. M.Pharm Nandha College Of Pharmacy,and Dr M.G.R University,

First(64.33%) 2010
(Pharmaceutics) Research.Erode, Tamilnadu. Channai,Tamilnadu.
2. Dr. B. A. M. U.
B. Pharm SBCOP, Aurangabad First(65.50%) 2007
Aurangabad.
3. Shri Shankarroa Mohitepatil
H.S.C. State Board,Pune First(65.17%) 2003
Mahavidyalaya,Akluj.

Personal Background:
Father Name & Address : Shri.Nagnath Pandurang Gaikwad
At Post :Ridhore (Barshi), Tal: Madha,
Dist:Solapur (MH) 413250.
Date of Birth : 24th Jan 1986
Nationality : Indian
Religion : Hindu
Marital status : Married
Languages known : English, Hindi, Marathi

References:
1. Mr. Pravin Kulkarni: Sr.Director CQA Emcure Pharmaceuticals Pune.91300029277.
Declaration:
I hearby declared that the above infomation given is true and correct to the best of my knowledge

Place: Pune Atul Gaikwad