COVER LATTER

NAME: DUSHYANT KUMAR S/O JAIRAM SINGH

ADD.: Village Prathvipur, Post Prathvipur, Dist. Bijnor (U.P)

PIN Code. 246701

COMPANY/ORGANIZATION: From Surgical Medical Device Company (Quality Control.)

TITLE: For Job Opportunity & Taking Challenges

Dear Sir/ Madam,

I am Quality Control Manager interested in interviewing for a position in Manager Regulatory Affairs & Quality Assurance in your organization. I believe that your organization has the ideal culture in which to pursue my goal of becoming a strategic leader business leader thinker.

My goal is to work in a globally competitive environment on challenging assignments that shall yield the twin benefits of the job satisfaction and a steady paced professional growth.

To be in a position in a result obtaining company that seeks an ambition and career conscious person where acquired skills and education will be utilized towards continuous growth and advancement.

I firmly believe that I will be a good fit in your organization’s collaborative entrepreneurial and intellectual culture.

I have enclosed my resume for your review. I would welcome the opportunity to participate in the personal interview to answer any of your questions and better present my qualification.

I am looking forward to hearing from you soon.

Sincerely,

Applicant’s Name: Dushyant Kumar

RESUME

DUSHYANT KUMAR PRESENT ADDRESS

H.no.242A,Block –E,1ST

60 foot road,Gali No. 16 M.B

Extension New Delhi110044. Mob.–999*******,946*******

E-mail: adqgu2@r.postjobfree.com

CAREER OBJECTIVE:-

To be responsible & efficient professional by working to the success of the organization willingness to accept challenges, work toward the growth of the organization.

EDUCATIONAL QUALIFICATION:

Intermediate Passed from U.P. Board, Allahabad in 2006 with IInd Div.

High School Passed from U.P. Board, Allahabad in 2001 with IInd Div.

PROFESSIONALQUALIFICATION:

B.Pharma Passed from U.P.T.U. Lucknow in 2014.

Registered Pharmacist with Uttar Pradesh council under Pharmacy Act 1948.

TRAINING:

40 days in Park Pharmaceuticals, Plot No. 172, Industrial Area, Phase-II, Panchkula.

One day training program of awareness ISO 13485at TUV Rehinland in Feb.2018.

PROJECT WORK:

Formulation & Evaluation of hard gelatin Capsule.

WORK EXPERIENCE:

Worked with -M/S Romsons International Unit -2 NSEZ Phase-2 Noida from 1,Jan2013 to 31,Dec2014. as a Quality Control officer.

Company Profile- An ISO 9001:2008,13485Drug certified medical Devices Company

Manufacturing all medical devices product i.e Anesthesia, Surgery, Urology, Transfusion, Gastrology products.

Worked with -M/S Paseca Healthcare LLP New Delhi from 1,Jan2015 to 8,Nov.2015 as a Quality Control officer (Approved Analytical Chemist).

Company Profile- An ISO 9001:2008,13485,Drug certified Medical Devices Company.

Manufacturing medical devices product i.e Anesthesia Surgery, Urology, Transfusion, Gastrology products.

Manufacturing of laparoscopic instrument and surgical Dressing.

Worked with -M/S Mediplus (India) Limited from 16,Nov 2015 to 5,Sep 2017 as Officer (Approved Analytical Chemist).

Company Profile- An ISO 9001:2008, ISO 13485:2016,Drug Certified Medical Devices Company

Manufacturing all medical devices product i.e I.V Cannula, 3-way Stop Cock.

Worked with -M/S Cardiomac India Pvt.Ltd. from 8,Sep2017 to 16 Jan 2021 as Quality control Manger( Approved Analytical Chemist).

Company Profile- An ISO 9001:2015, ISO 13485:2016,Drug Certified medical Devices Company

Manufacturing all medical devices product i.e 3-way Stop Cock with Extension tube, Aspiration Catheter, Cardiovascular Catheter, Angiographic Catheter, Hemodialysis Catheter,Center venous catheter Etc.

Currently Working with -M/S Advanced lifesncciees Pvt. Ltd. from 20 jan.2021 to till day as Quality control Manger (Approved Analytical Chemist).

Company Profile- An ISO 9001:2015, ISO 13485:2016,Drug Certified medical Devices Company

Manufacturing all medical devices product i.e 3-way Stop Cock with Extension tube, Manifold,Cardiovascular Catheter, Guide wire, Hemodialysis Catheter,Center venous catheter, Wedge Pressure Catheter, Arterial Filter,Aortic Punch,Aortic root Cannula Etc.

Technical Skills:

Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data

• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.

• Demonstrated understanding of related fields (Medical Device manufacturing, analytical testing, and, Quality Assurance).

• Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems

Leader Skills: Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.

• Demonstrated flexibility in responding to changing priorities or dealing with unexpected, events.

• Capability to handle multiple priorities and balance work to achieve business goals.

• Demonstrated effective leadership, communication, and interpersonal skills.

Keyskills:Qualitycontrol,ISO13485,QMS,ISO10993,PMS,MDD/93/42/EEC,MDR/2017/745,ISO 14971:2019,CDSCO,QMS.

JOB PROFILE:

A competent professional with nearly 8.10 years of experience in:

1.Quality control & quality assurance

2.Quality Management system ( ISO:13485, MDR 2017 )

3.Product Clinical Evaluation.

4.Risk Management (ISO: 14971:2012)

5.Packaging Validation.

6.Team Management

7.QMS Implementation

8.Certification with, MDR

9.Frequently certification, Free sale, Manufacturing & Marketing certificate

10.Process of sterilization Validation as 11135.

11.Validation of HVAC (ISO-14644)

12. Managing Internal Quality Audits and organize Management Review meetings.

13. Risk analysis and Risk management as per ISO 14971(2012)

Biological test:

Environment monitoring

Clean Room Monitoring By Settling plate method

Bio burden test

Validation of laminar flow

Serial dilution

MICROBIOLOGICAL TEST

Sterility Test.

BIOCHEMICAL TEST

LAL (BET) Test.

CHEMISAL TEST

Physico- Chemical Test.

OTHERTEST

Incoming Material Testing.

Finished Goods Testing.

OTHER WORK:

Validation of ETO Sterilizer

Validation of Clean Room.

Validation of Autoclave.

Calibration of Instruments

Drug Regulatory and ISO 9001 & 13485 documentation work, Quality assurance for all Product manufactured at plant.

In charge of entire Quality Control and process validation.

Implementation of ISO13485:2016 at plant, Acting as management representative as Pre ISO and MDR 2017

Domestic and International Regulatory Affairs.

Play A key role in Getting Manufacturing license, Free sell certificate, Loan License etc From CLA as well as SLA with Sugam Portal.

Certification, whole sale license, free sale certification, product approvals for manufacturing.

PERSONAL INFORMATION

Name : DUSHYANT KUMAR

Date of Birth : 2ndApril, 1986

Father’s Name : Shri Jairam Singh

Marital Status : Married

Gender : Male

Nationality : Indian

Language Known : Hindi & English

Hobbies : Listening Music & Sports

Permanent Address : Village. & Post. - Prathvipur, Distt- Bijnor (U.P.) 246701

DECLARATION:

I hereby declare that the above information is best on the truth and is best of my knowledge.

Date:

Place: (DUSHYANT KUMAR)

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