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Software operator and Documentation

Location:
Barabanki, Uttar Pradesh, India
Salary:
5000ADE
Posted:
January 29, 2020

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Resume:

CURRICULUM VITAE

Nitin Kumar Verma

Nitin Kumar Verma

Vill. to Post Bhetaura Lakhan,

Zaidpur,

Teh:-Haidergarh

Barabanki

Pin Code:-225414, Utter Pradesh.

(M): +917*********, 945-***-****

Email :- adbhv8@r.postjobfree.com

Objective

CAREER OBJECTIVE:

Seeking a professional career in EDCS, EBRM, EQMS Software which will provide unlimited growth, opportunities, suitably enhances my skills, provides me a challenging environment demanding all my domain knowledge and efforts to explore and strive hard for organizational and personal growth by well-coordinated team work.

PERSONAL SUMMARY

CURRENT ASSIGNMENT.

Presently Working Acme Generics LLP in as a Sr.Officer in Quality Assurance Department.

1.Handling of Electronic Document Control System (EDCS)

2.Documentation Control Issuance and Retrieval of:

a)Standard Operating Procedure

b)Specifications / Standard Test Procedure

c)Bill of Materials / Master Packaging Instructions

d)Protocol / Reports

e)Master Formula Card

f)Reference Document

3.Documentation Room Management

a)Issuance of Master Documents

b)Archival of Master Documents

4.Issuance and Retrieval of BMRs/BFRs/BPRs (EBRM)

a)Issuance of Batch Records

b)Retrieval & Archival of Batch Records

5.Handling of Electronic Document Control System (EDCS)

a)Entry, Uploading, Modification And Printing Approval of Document

b)Archival of Issued Document

6.Handling & Arrangement of SOP Documents

7.Distribution of Document

8.Preparation and Maintenance of Indexes

9.Preparation of Instrument Numbering List

10.Experience in Validation Protocol like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and Validation report including life cycle validation documents.

11.Experience in writing test Script, test plans and procedures. Experience in development of Standard Operating Procedure (SOP) as per regulatory requirement.

Educational & Professional Profile

ACADEMIC CREDENTIALS:

COURSE

COLLEGE/SCHOOL

BOARD

YEAR

MARKS

B.sc.

Dr. Ram Manohar Lohia Avadh University Faizabad (U.P)

A.U

2015- 2017

51.6%

10+2 (Science)

S K L M P Inter college Dighawan Barabanki

U.P

2014

62.9 %

10th

Noor Mohamed Inter college zaidpur Barabanki

U.P

2006

49.38 %

WORK EXERIENCE

Duration

:

Since 28 May 2018

Company

:

Acme Generic LLP

Designation

:

Sr. Officer

(QA- Documentation )

Duration

:

11 May 2012 to 04 Mar.2018

Company

:

Fresenius Kabi Oncology Ltd.

Kishanpura - Baddi

Designation

:

Supervisor (QA – Documentation)

Audit Faced

USFDA

:

Software Qualifiction :- EDCS, EBRM, MTS

User managment Complaince

MHRA

:

TGA

:

Belarus

:

EU

:

UGANDA

:

Columbia

GCC

Turkey

ANVISA

Time Line Map

June

2006

May

2014

June 2015

June 2017

May 2018

May

2011

Mar.

2018

10th

10+2th

B.Sc.

Acme Generic LLP

Fresenius Kabi Oncology Ltd.

(Supervisor QA Documentation and

IT Compliance)

Personal Details:

Father’s Name

:

Mr. Makrand Kumar verma

Mother’s Name

:

Mrs. Manorama verma

Date of Birth

:

17-Jan-1991

Sex

:

Male

Marital Status

:

married

Nationality

:

Indian

Language

:

Can Speak/Read/Write: English, Hindi,

Passport no.

:

P9770408 (Expires on: 05/05/2027)

My Strength

I have faith on myself. I am flexible, creative, enthusiastic, self-motivated, self-confident & extremely hard working.

Declaration:

I hereby declare that above Information and particulars are true and correct to the best of my personal knowledge and belief.

Place: Barabanki. Date: 03/12/19 Signature: Nitin Kumar verma



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