NEERAJ KUMAR PATHAK

H-No-114, KH No-548, Sultanpur Extn., New Delhi – 110030, INDIA.

Phone: +91-9457 195 535, +91-9167 912 185, Email: neerajpathak1989@gmail.com

[Certified Lead Auditor for ISO 9001 & ISO 13485]

[For Regulatory Affairs, Internal Auditor for ISO 9001, ISO 13485 & CE Marking]
Current CTC: 5.23 L P/A, Expected CTC: 6.5 L, Notice Period 2 Months.

Carrier Object:
 To work in a challenging job environment that utilizes my skills and ability and offer sample
learning opportunities.

Educational Information:
 MBA (Integrated) with B. Tech. (Biotechnology) in 2012 from Mangalayatan University,
Beswan, Aligarh, (U.P).
 Intermediate (PCB) in 2007 from U.P. Board.
 High school (Science Stream) in 2005 from U.P. Board.
Additional Qualification, Training / Project:
 Six months academic Research project on Antimicrobial activity of Calotropis Procera plant
against Staphylococcus aureus.
 Three (3) months and 15 days in Q.C (Chemical analysis or Microbiology Sterility department) as
trainee at Ciron Drugs & pharmaceuticals Pvt. Ltd. Jogeshwari (W), Mumbai Maharashtra,
India.
 One (1) month in Molecular diagnostics department, as trainee at Auroprobe laboratory, from
Modinagar, Ghaziabad, U.P, India.
 One (1) month and 12thDays in Finance & Accounts Department, a trainee at Free India
Assurance Services Limited From Mumbai, Maharashtra, India.
 Attended three (2) days International colloquium on biotechnology (ICB-09) in DAB collage,
Jalandhar, Punjab, India.
 Attended a scientific seminar in collaboration with American society for clinical pathology in
Delhi University, Delhi, India
 Poster Presentation of my research work on Antimicrobial activity of CalotropisProcera plant
against pathogen stain of Staphylococcus aureus in a National conference at Mangalayatan
University, Beswan, Aligarh, (U.P), India.

Last Updated on: 12/Sep/2017

Currently Working:

With M/s. GST Corporation Limited., New Delhi as the post in Asst. Manager Regulatory Affairs
from May/2016 to till date.

Working Experience:
 01 year and 09Months in M/s Dhanuka Laboratories Ltd., Gurgaon, Haryana, from
May/2012 to Feb/2014 as the post in Q.C Microbiologist cum Regulatory Affairs.

 01 year and 01 Months in M/s GASR Faridabad, Haryana from Feb 2014 to March 2015 as
the post in Exe. Regulatory Affairs (Certification Auditor/Technical Expert For ISO 9001,
ISO 13485 and CE Marking for Medical Devices).

 01 year and 01 Month in M/s Advanced Lifesciences Pvt. Ltd., New Delhi from Apr 2015 to
Apr 2016 as the post in Incharge Regulatory Affairs.

Total Working Experience:

 05 Years and 02 months till Month of Aug 2017 as in the field of Microbiology and
Regulatory Affairs.

Current Job Responsibilities:

 Preparing Review or Updating Technical Documents like:

o Product Technical File,
o Risk Analysis as per ISO 14971:2012,
o Product Clinical Evaluation as per MEDDEV 2.7.1 Rev. 4 June 2016.
o Product Quality Manual and Procedure Manual as per ISO 13485:2016.
o Participating in Management Review Meeting and maintaining its records.
o Reviewing Product Art work (Product label) as per requirement of EN 980:2008.
o Reviewing or updating All QMS Records.

Last Updated on: 12/Sep/2017

  Performing Internal Audit as per Requirement of ISO 9001:2015, ISO 13485:2016 & CE
Marking (MDD/93/42/EEC) and maintaining its records.
 Providing Training on Understanding ISO 13485:2016, ISO 9001:2015 & CE Marking and
Maintaining its Records.
 Preparing and submission of Documents to DGFT for Free Sale and Commerce Certificate.
 Prepare and submission of Documents to Drug Controller Department for Free Sale
certificate, renewal of wholesales license.
 Prepare and submission of Documents to Department of consumer affairs weights and
measurements unit for model Approval and import registration.
 Prepare and submission of Documents to State Food Office for FSSAI License
(Manufacturing and Retail).
 Preparing and arranging Technical documents for Registration of Medical device in Foreign
Countries as per legal Requirements of Respective Countries.
 Preparing Bar-code and update product information on GS1 India’s website.

Previous Job Responsibilities (M/s. Advanced Lifesciences Pvt. Ltd.):

 Preparing Review or Updating Technical Documents like:

o Product Technical File,
o Risk Analysis as per ISO 14971:2012,
o Product Clinical Evaluation as per MEDDEV 2.7.1 Rev. Dec 2009.
o Product Quality Manual and Procedure Manual as per EN/ISO 13485:2012.
o Participating in Management Review Meeting and maintaining its records.
o Reviewing Product art work (Product label) as per requirement of EN 980:2008.
 Performing Internal Audit as per Requirement of ISO 9001:2008, EN/ISO 13485:2012 & CE
Marking (MDD/93/42/EEC) and maintaining its records.
 Providing Training on Understanding EN/ISO 13485:2012, ISO 9001:2008 & CE Marking
and Maintaining its Records.
 Getting legal Authentication (from Chamber of Indian Trade & Industry, Ministry of External
Affairs, and from Respective Country’s Embassy) on required papers for export or register
product in respective country.

Last Updated on: 12/Sep/2017

  Submission of Product Technical Documents, Legal Documents to DCGI Office for Product
Registration, and for Import of Medical Device.
 Preparing and arranging Technical documents for Registration of Medical device in Foreign
Countries as per legal Requirements of Respective Countries.

Last Previous Job Responsibilities (At GASR):

 Certification Audit as Trainee Auditor for EN/ISO 13485:2012, ISO 9001:2008, ISO 22000,
ISO14001 & Technical Expert for CE Marking for Medical devices as per Medical Device
Directive 93/42EEC and EN/ISO 13485:2012.
 Review Technical Documents
All QMS and Technical Documents and Records as requirement of ISO 9001:2008, EN/ISO
13485:2012, and CE Marking like:
o Product Technical File
o Product Risk Analysis.
o Product Clinical Evaluation Report.
o Product IFU, Label, and Post market surveillance report.
o Quality manual and Procedure Manual
o Internal Audit Record.
o Management Review Meeting.
o Customer Complaint and Feedback record.
o Employee Training record.
o Product Technical Test Reports and Packaging, Clean room and Sterilization
Validation Report, Etc.
 Preparing ISO/CE Marking Certification Audit Report for respective Notified or Certification
Body.
 Third Party Inspection, PDI (Pre-Dispatch Inspection of Medical Devices).

Last Previous Job Responsibilities (At M/s Dhanuka Laboratories Ltd.):

 Preparing Protocol and Validation Report for Steam Sterilization Validation and Clean Room
Validation.
 Day to day collect water or Product’s sample for microbial and Chemical Analysis

Last Updated on: 12/Sep/2017

  Maintaining or preparing Documentation Process for Q.C Microbiology.
 Compiling of Registration Dossiers Module 1 to Module 5 of Domestic Regulatory.
 Coordinating with different departments like CQA, IB QA/QC & Compile dossiers within
Specified time limit and submit to Consultants and respond on queries raised after
submission.
 Compiling of DMF for API, Stability data, Specifications, Art Works, BMR Reports, and STP
used in the Module 3.
 Preparing Quality Manual as per ISO 9001:2008.
 Preparing Quality Procedure as per Requirement of ISO 9001:2008.

Technical Skills

(a)-Microbiology:
 Sterility test.
 Bio-burden Test (MLT).
 Identifying Pathogen.
 Sterilization Validation.
 Clean Room Validation
 Antimicrobial test.
 Environmental Monitoring Test:-
 Air sampling of different areas (production or packaging).
 Finger dabs.
 Swab Test.

(b)- Water Analysis:

 TDS, Conductivity, PH Analysis.
 Hardness Analysis.
 Heavy Metals Analysis.
 Chlorine, Nitrate Determination, oxydisable substance.

(c)-Handling instruments:

Last Updated on: 12/Sep/2017

  PH meter, Conductivity meter.
 BOD Incubator.
 Autoclave.
 Hot Air Oven.
 Laminar Air Flow (LAF).
 Colony Counter.
 Antimicrobial Zone Reader.
 Water Bath.

IT skills-windows, MS Office and Internet Applications:

Proficient in MS Office and Internet Applications.

Languages known:
 English& Hindi

Personal detail:

Father’s name : Rishi Kumar

Date of birth : 10, Apr, 1991
Sex : Male
Marital status : Unmarried
Nationality : Indian.

Permanent Address:
Vill. - Beloth, Post - Karas, Dist. - Aligarh, UP – 202124, INDIA.

Last Updated on: 12/Sep/2017