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Management Quality

Location:
Bharuch, Gujarat, India
Posted:
March 09, 2019

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Resume:

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Curriculum Vitae

PERSONAL DETAILS

Name : Nipun Shankarbhai Patel

Correspondence Address : A/64, Shikhar Bunglows, Near : Prarthna School. Bholav, Bharuch. 392015

Gujarat, INDIA

Cell No : +91-992*******/910-***-****

E-mail : ac8qa8@r.postjobfree.com

Date of Birth : 01st June 1973

Nationality : Indian

Gender : Male

Marital Status : Married

Languages Known : English, Hindi and Gujarati.

EDUCATIONAL DETAILS :

Sr.

No.

Exam / Course Institute / Board Year of

Passing

Result

1. S.S.C Shreeji Krupa Sarvajanic

Vidhyalay, Koliyad. Dist: Vadodara.

Higher Secondary Education

Board, Gandhinagar

1989 52.00%

2. H.S.C The Palej High School, Palej, Dist:

Bharuch.

Higher Secondary Education

Board, Gandhinagar

1991 60.00%

4. Diploma in

Computer

Programming

with (ORECLE 8I).

C-DAC Computers, Bharuch,

(A GOVT Approved Institute)

2000 89.00%

WORKING EXPERIENCE :

Assistant (QA):

1) Sun Pharmaceutical Industries Limited, Ankleshwar “Quality Assurance” Department, From 01-07-1994 to March 2008

Functionality:

Final Materials Dispatch activities.

Page: 2 of 3

Maintain WRS and it’s record.

Maintain Laboratory Chemicals stock and it’s record.

Maintain Dispatch Packing Materials stock and it’s record. Sr.Officer I (QA/QC):

2) Sun Pharmaceutical Industries Limited, Ankleshwar “Quality Assurance & Quality Control” Department, From 01 April 2008 to September 2014.

Functionality:

Project: Laboratory Information Management System: (LIMS) Laboratory Information and Management System is a software system used in laboratories for recording all laboratory related activities which includes Sample Management, Instrument & Reagent Management, Standard Management, Product Stability, Laboratory User Management and Statistical Data and Reports about transactions. Integrated workflow provides complete traceability and laboratory data management in a manner compliant with the strict standards of the US Food and Drug Administration Regulation 21 CFR Part 11 system and email configuration to track the status of samples, documents, Laboratory Instruments and solutions.

Role : LIMS administrator.

Responsibilities:

Leading a team of 23 members from Analysis work, Testing, Documentation, Implementation and Support group for development, implementation and global rollout support of In house developed Laboratory Information Management System.

Application owner of QC LIMS, Stability Solution and APR

Worked with internal / external auditor to make LIMS solution more compliant and process oriented.

Responsible for quality application implementation strategy including gap analysis, designing and finalization of validation plan.

Additional Responsibilities:

New implementation & Version module training.

User support

Software Testing & Validation.

Trouble Shooting with Live support on user work place.

Document generation:

Product Specification and Analytical Test Procedure,

User Manual of LIMS, Reports

Product Trend Reports through LIMS.

Product Stability Reports through LIMS.

Prepared URS (User Requirement Systems)

Prepared Monthly Analysis and Specification Report through LIMS.

Preparation Documents of SOP (Standard Operating Procedure)

Preparation Documents of QMS (Quality Management System) Page: 3 of 3

Sr.Officer (QA/QC):

3) Filatex India Limited, Dahej “Quality Assurance & Quality Control” Department, From 18th October 2014 to July 2018.

Responsibilities:

User support

Software Testing & Validation.

Trouble Shooting with Live support on user work place.

Document generation:

Product Specification and Analytical Test Procedure,

Preparation Documents of SOP (Standard Operating Procedure)

Preparation Documents of QMS (Quality Management System) Contact : Direct +91-992*******)

Period required to join : 30 Days from intimation to me Date : 17th Aug, 2018

[ Nipun S. Patel



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