AJAY DHASMANA

HEAD QUALITY ASUURANCE AND REGULATORY AFFAIRS

Address:Flat No.162-2, Upper ground floor, Krishna Park , Devli New
Delhi-110068, M. No. 9958932657, E-mail: [email protected]

Profile Summary
 Approved analytical chemist for suture from Delhi drug control department and B.Sc.
(Physics, Chemistry & Mathematics) offering 18 years of experience in Medical Devices
Like Disposable Syringes, IV sets, Surgical Suture, Blade And scalpel, gauge ,tape,
bandages and Research and Development (R&D), N95 Mask, 3Ply mask, implantable
screws, pin with hands-on experience in managing laboratory operations, documentation,
instrument (troubleshooting, maintenance & calibration), validation and quality control,
quality assurance & regulatory affairs.
 Recently completed the INTERNAL AUDITOR certification training course for ISO
13485:2016 and EU MDR 2017/ 745 From INTERTEK on 15 May 2021.
 Executed a wide gamut of functions including Audits, Customer complaints, Corporate
Relations, Training, certification & Empanelment; bagged high remarks during each audit.
 Insightful knowledge on international standards like D&C 1940, ISO, MDSAP, ICMED
MDD/MDR & schedule-MIII with expertise in documentation.
 Steered the completion of drug, ISO, GMP, GLP audits as a Head QA & MR at Super
Surgimed Pvt Ltd.
 Currently Steered the completion of ENISO 13485:2016, BIS, CE, CE for mask, MDSAP,
ICMED, Customer audits as a Head QA & MR at Paramount Surgimed Ltd.
 Experience in managing strategic & operational performance of Quality Department
involving development & implementation of standardized quality systems.
 Skilled in working with instruments like Tensile meter, Karl Fisher Titrator, Water Bath, Ph
Meter, Conductivity Meter, Profile Projector, hardness testing etc.
 Highly passionate integrated & energetic leader known for skills to envision & create SOP,
Manuals and guide members with latest knowledge & modern skills on standards and
Product Development.

Key Skills
Laboratory Operations & Maintenance, Training of ISO/CDSCO, SOP Preparation & Implementation
Good Documentation, Drug Applications, ISO certification, GMP,GLP ,Instrument operation,
Calibration and Maintenance, Quality Control, Quality Assurance, Regulatory affairs, Analysis &
Testing, Audits/ Continuous Process Improvement / CAPA/ Risk Analysis, Training & Team
Management
 Certifications/ Trainings
 Approval letter of analytical chemist from Delhi drug control department
 Analytical staff Training Certificate from NIPER, Mohali, Punjab.
 ISO 9001-2008 Training from SGS, Gurgaon in the year 2013.
 CDSCO Training for NABCB, LAC at Lodhi road, New Delhi in the year 2019
 Internal audit training for ISO 13485:2016 and EUMDR 2017/745 in MAY 2021.

Educational qualification:

Examination Board/university Year of Passing % Of marks Division

10th U.P. Board 1995 51.5% IInd
(Allahabad)
10th+2 U.P. Board 1998 58% IInd
(Allahabad)
B.Sc. (P.C.M) Garhwali University 2001 54.5% IInd

Technical qualification:

One-year Diploma in Computer Software from I.E.C. Kotdwara (U.K.) Package known (Dos,
Windows-98, MS- Office, Word, Excel, and PowerPoint, net surfing)

Job Timeline (Recent 4 Companies)

SUPER Paramount
Jan 2014- SURGIMED Nov 2018- Surgimed Ltd.
Sep 2016 PVT. LTD Feb 2020

JAI SURGICAL DATT MEDI-

LTD. RODUCTS Since Feb
Sep2016-Oct
PVT.LTD 2020
2018
Work Experience

Since Feb’20 working with Paramount Surgimed Ltd. Okhla, Delhi and Bhiwadi as Head of the
department QA/QC/RA & Reporting to MD / CEO .

Key area
 Establish, implement, and maintain the ENISO 13485:2016, MDSAP, ICMED, BIS, CE, CE
Mask, ISO for mask
 All audits (ENISO 13485:2016, MDSAP, ICMED, BIS, CE, CE Mask, ISO for mask)
 Response to the international customer’s queries
 CAPA implementation
 Training to the personnel

Previous Experience
Nov’18 worked with Datt Mediproducts Pvt. Ltd., Sohna, Gurgaon as Assistant General
Manager Quality Assurance QA/QC/RA & R&D; Reporting to VP & MD.

Key Result Areas:

 Preparation of all clauses mentioned in Drugs and Cosmetic Act standard to get drug license
from Drug Department and AYUSH department for Ayurvedic drug.

 Heading the entire QA/QC/RA functions; perforating calibration, maintenance &

troubleshooting of instruments.

 Facilitating quality control (internal and external) procedure development for testing of
medical device

 Interfacing with the certification bodies and contributing in the development of

infrastructure, quality manuals, SOPs for instruments, formats & raw data reports

 Developing Quality Control by monitoring incoming, in-process and final inspection of

procedures, records & documentations

 Conducting regular audits for process compliance and ensuring adherence to GMP & GLP
standards

 Building & maintaining a Quality Risk Management System to adequately control risks,
ensuring harmonization between chemical & formulations processes.

 Adhering to the rules & regulations and maintaining cordial relations with Govt.
Organizations/ Regulatory /Certification Bodies like ISO, CE, and CDSCO.

 Planning staffing needs and driving recruitment of right talent for building an effective
team.
 Mentoring & monitoring the team performance to ensure efficiency in process, providing
training to the team on instrument handling and establishing effective audit programs

Sep’16-Oct’18 worked with Super Surgimed Private Ltd. as HEAD QA & MR (PROJECT HEAD)

Highlights:

 This site construction has been completed under my supervision(brick work, Wall panel,
ducting, Painting, Electric Transformer and connection, Machines, Lab chemicals and
glassware’s, RO plant installation, DM Water plant installation, Compressor, Air piping,
AHU, Furniture’s, Gauges, ETO Sterilizer installation and validation, clean room validation,
flooring, Logo and Artwork, Website development, Application for New Drug license, free
sale certificate, no conviction certificate, state GMP, ISO 13485-2016),Licensing from
CDSCO (Sugam portal) as per MDR 2017,.

 Performed complete preparation of all clauses mentioned in Drugs and Cosmetic Act
standard to get drug license from Drug Department.

 Performed complete preparation of all clauses mentioned in ISO 13485-2016 standard to

get certificate from notified body.

 Performed complete preparation of all clauses mentioned in Drugs and Cosmetic Act
standard to get GMP from Drug Department.

Jan’14-Aug’16 worked with Razor med Inc. Gurgaon as Head QA/QC

 Steered the completion of ISO, CE, and Customer Inspection as a Head quality assurance.

 Successfully work on design and develop the dimension of the mold for safety scalpel
against customer complaint.

Jan’13-Dec’13 worked with SRS Meditech ltd. Kasna ,G Noida as Quality Engineer

 Successfully executed drug audit, ISO Certification, Surveillance Inspection as a quality

engineer with the team.

Aug’’03-Nov’12 worked with Stericat, Badarpur/Noida NSEZ, Delhi as Head QA

Growth Path at Stericat Now Peter Surgical Pvt. Ltd.:

2003-2005 Lab Assistant
2006-2007 Approved analytical staff
2007-2012 Head QA/QC

Highlights:
 Participated in a Seven Days National Training Program especially for Analytical Staff at
NIPER (National Institute of Pharmacology Education and Research) and secured second
position during the Evaluation out of forty-one participants.

 Successfully design and develop the chromic suture breaking and fraying problem against
the customer Complaint.

 Successfully design and develop the vacuum and drying process for the hygroscopic
material against customer complaints.

 Successfully design and develop the needle to suture attachment process to achieve 100%
quality and 0 rejections against customer complaint.

 Participated in a one-day Training Programmed about Sterilization Process Validation.

 I have prepared and maintained the Documents as per WHO GMP Norms, ISO 13485-2003,
ISO 9001-2008, CE, and Drug Requirement

Personal Details
Father’s Name : Late Jagat Ram Dhasmana.
Mother’s name : Smt. Sarasvati Devi
Date of Birth : 05/11/1980
Marital Status : Married
Sex : Male
Religion : Hindu
Nationality : Indian
Salary drawn : 1200000 / P.A. + Car
Expected Salary : Negotiable
Language known : Good Skills in English / Hindi
This is to certify that the given above information are true and belief my knowledge.

Place: ------------------

Date: ---------------------

Ajay Dhasmana

Signature