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Sr. Middle Level

Management Professional

Operation Management

Quality Control

Personal Details

Date of Birth:

9th Jan 1981

Languages Known:

English, Hindi, Gujarati

Address :

H 203,Binori Park Ridge, Near

Swastikkrut Apartment,

Bopal, Ahmedabad,Gujarat,

India

Profile Summary

Quality Control function:

Expertise in handling and managing various instruments i.e. HPLC, GC, IR, UV-VIS Spectrophotometer, Polari meter, Karl Fischer, Melting Point Apparatus, Dissolution Apparatus, Disintegration Apparatus Handling of incidents, out of specification and out of trend results Trouble shooting during Analysis

Generation of Standard Operating Procedures, Test Methods and specifications for quality control

Handling of retained sample & their periodic observation Raw material, Packing material & finish product report review and release in SAP

Stability study of finished product

Management of Reference standard and working standard Provide training to the new analyst and their qualification Plan Annual Maintainance Schedule.

Core Competencies

SOP improvements Technology Transfer

Operation Management QC Function Certification – USFDA, EDQM & KFDA Team Building / Man power Management QC Training & Leadership Handling of customers Vendor Qualification

Sanjay Nagar

Quality Control Management

Pharma API & Formulation

Expertise in managing QC function of Chemical, API and Formulation adoac8@r.postjobfree.com +91-886*******

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Career Timeline

Concord

Biotech ltd

March 16 till date

May 15 – Mar 16

2007

Jun 12 – May 15

Dec 11 – Jun 12

Rusan

Pharma Ltd

Dishman

Pharmaceutic

als & Che. Ltd

Torrent

Pharmaceuticals

Ltd

Astron

Research Ltd

Aug 08 – Dec 11

Dec 05 – Aug 08

Jul 04 – Dec 05

Dec 02 – Jul 04

Cadila Health

Care Ltd.

Unimark

Remedies Ltd

Halcyon Labs

Pvt Ltd

Organizational Experience:

Concord biotech Ltd., Ahmedabad

Sr. Asst. Manager, QC

Job Profile:

Plan work allocation on daily basis.

Handling stability Department as In- Charge

Provide training to the new joining

Handling of Market complaints and Approved vendors

Preparation of SOP, Specifications and Test methods.

Review of in processed, intermediate and finished product report

Analytical protocol and prepared their COA.

Reference standard and working standard management

Handling of Incidents, Change control and OOS

Rusan Pharma Ltd., Ankleshwar

Asst. Manager, QC

Job Profile:

Approval of Raw material & Packaging Material report

Review of Finished Product report

21 CFR compliance work.

Vendor Qualification

Training to the new analyst and their Analyst qualification

Handling of Incident, Change Control & OOS

Preparation of new SOP, Test method and their Specification Dishman Pharmaceuticals & Chemicals Ltd., A’ bad

Executive QC

Job Profile:

In-charge of quality control department

Review of Raw material, Packaging material and finished

Co-Ordinate with QA for Change Control related to SOP Torrent Pharmaceuticals Ltd., A’ bad

Executive QC

Job Profile:

Working in GLP Department

Responsible for Revision, preparation and Obsolete of SOPs

SOPs Training to the new joiner

Issuances of Log Book, Register, and Calibration protocols

Reporting to the Manager

Astron Research Ltd., A’ bad

Sr. Research Associate

Job Profile:

Product stability study

Review of calibration report

Cadila Healthcare Ltd., A’ bad

ADL Officer

Job Profile:

Product stability study

Review of calibration report

Unimark Remedies Ltd., A’ bad

ADL Chemist

Halcyon Labs Pvt. Ltd., A’ bad

QC Chemist

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Achievements

Academic Details

Certified as an approved Technical Person in Physicochemical and Chemical Testing from Food & Drugs Control administration, Gandhinagar, Gujarat

Reworded by Managing Director on Successes fully completion of K FDA and US FDA Audits in Dishman Pharma

Reworded by Managing Director on Successes fully completion of EDQM Audit in Rusan Pharma

M.Sc. (Chemistry) with 56% from Madurai Kamraj University. Direct Distance Learning with Practical Training in 2005-2007

PGD-Export-Import Management with 55% from Gujarat University.

B.Sc. (Chemistry) with 56% from Gujarat University in 1998-2001 Skill Set

End of CV

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