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Quality Control Pvt Ltd

Location:
United States
Posted:
August 31, 2012

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Resume:

V.Sankara Narayanan

Mobile: 0-989*******, 093********~ E-mail:wkgshf@r.postjobfree.com

MANAGEMENT PROFESSIONAL

~ Quality control~ micro Lab setup ~ Equipment Qualifications ~Validations

PROFESSIONAL PROFILE

Experience Profile

Quality control with 6 years of experience with well-known organisations across the quality checking of raw material finished product and New lab set up.

Currently designated at Wockhardt Ltd., Aurangabad as Executive, Quality control.

Core Competencies Evolved

Abilities in harmoniously managing day to day tasks with a talent for quality control activities Management in line with Industry Best Practices.

Notable Career Highlights

New lab set up.

All activities to ensure timely completion of projects.

IQ, OQ & PQ of area or lab.

IQ, OQ & PQ of Equipments/ Instruments.

Preparation of validation protocols.

SOP/STP preparations.

Test data sheet preparations.

Sterility of finished product, raw materials etc.,

Bacterial Endotoxin Test for finished product and raw materials.

Microbial limit test for materials and water.

Decision-making.

Co-ordinating with senior to complete the task.

Participation in preparation, development and maintenance of Quality Management System.

Areas of Expertise

Quality control activities

Routine analysis of finished product and raw materials.

Environment monitoring techniques.

Studying process and suggesting development of product validations.

Preparing analytical flow chart and control plan for daily lab activities.

Validations

Sterility validation of finished product, raw material and packing material.

BET validation of finished product and raw material and packing material.

MLT validation of finished product and raw materials.

PET/AET validations.

Antibiotic assay validation.

Non-routine validations.

Qualifications

New area qualifications.

IQ,OQ and PQ of instrument/Equipments.

Autoclave qualifications.

DHS qualification.

Water system qualifications.

Audit participated

Successfully participated with USFDA,MHRA,TGA,UNICEF, WHO etc.,

Trainings Attended

Attended and conducted training programs to make awareness for aseptic techniques, Basic microbiology techniques etc.,

Career Highlights:

Organization Designation Period

Scope of Experience

Wockhardt LTD., Aurangabad.

Executive QC

Nov 2008 to till date Heading total microbiology laboratory activities.

CIPLA LTD., (Oncocare inj.,) Goa. Section in charge

Jan 2006 to Nov 2008 Looking after testing of finished product, raw material and environment monitoring activites.

Sun pharmaceutical

Gujarat. Section in charge Mar 2005 to Jan 2006 Heading total microbiology laboratory activities.

Indchemie Health Pvt., Ltd., Daman. Microbiologist Sep 2003 toMar 2005 Analysis of water, finished product, raw material and environment.

The Heart institute. Chennai. Research scholar May 2002 to Sep 2003 Research work in Rheumatic fever (Cardiac disease)

Career Path;

Research scholar : 2002

Microbiologist : 2003

Section incharge : 2006

Executive QC : 2008

Wockhardt LTD., Aurangabad

Executive Quality Control Nov’08 – Till date

Wockhardt is a global pharmaceutical and biotechnology company with market capitalization of over US$ 1

Billion annual turn over US$ 650 million. It is distinguished by a strong and growing presence in the worlds

Leading market.

Working with Cephalosporin Unit, Aurangabad. (USFDA,MHRA approved), as Executive Quality Control from Nov 08 to till date.

Heading laboratory activities like work distribution, monitoring of timely analysis and on-line reporting etc.,

Successfully handled New lab set up.

CIPLA Ltd., (Oncocare ind pvt ltd.,) Goa Jan ’06 – Nov’08

Section in-charge

Cipla is the India’s second largest pharmaceuticals with the cross income of 4309 crore / year. This oncology unit is the manufacturer of anti-cancer injection having approval of USFDA, MHRA, TGA, UNICEF & ANIVSA etc.,

Worked with Oncocare Unit-V, (Cipla) Goa for around 3 years as a section in-charge.

Activities like distribution of work and monitoring of analysis and timely completion of reports. Involved with the validation and qualification of product and equipments like Autoclave, DHS etc.,

Successfully participated with 3 USFDA audits, 2 MHRA audit, ANVISA etc.,

Sun pharmaceutical Ltd., Gujarat. Mar 05– Jan 06

Section in-charge

Sun pharma is No-1 in India in specialty therapy like psychiatry, neurology and cardiology. Brands in 30 world wide markets.

Worked around 1 year in tablet and capsule manufacturing at Silvassa plant.

Successfully faced WHO audit and heading the microbiological analysis like water, finished product, environment monitoring, validations etc.,

Indchemie Health Pvt Ltd., Daman Sep’ 03 -Mar’05

Microbiologist.

Indchemie health Pvt., Ltd., is one of the leading manufacturer of soft gelatin capsules. Having approval of WHO and TGA.

I was working as Microbiologist around 1.5 years. Analysed water samples, finished product, raw material.

Vitamin assay, environment monitoring etc., successfully faced WHO and TGA audits.

The Heart Institute., Chennai May 2002 - Sep 03

Research scholar

Worked with the projects about rheumatic fever which is caused by streptococcus infection. Submitted project

thesis about rheumatic fever.

EDUCATIONAL QUALIFICATIONS:

Examination

Passed Board/

University Institution

Attended Year Class

M.Sc.,

Microbiology M.S University

Tirunelveli.

Tamil Nadu Shri Parama Kalyani college. Tirunelveli.

Tamil Nadu. April 2002

First

B.Sc.,

Botany with Applied Microbiology. M.S University

Tirunelveli.

Tamil Nadu St. Xavier’s college of arts & science. (5 star)

Palyamkottai.

April-2000 First

ADDITIONAL QUALIFICATIONS:

Diploma in Computer Application (DCA)

English type writing - higher

Student training and actions for neighbor hood development

Personal Vitae

Languages known : Tamil, English, Hindi

Date of Birth : 24th July 1979

Marital Status : Married.

Permanent Address : 28 A, Near senai thalivar high school,

Vickrama singa puram, 627 425.

Tirunelveli dt.,

Tamil Nadu.

Mobile No. : 098********,093********.

Email ID : wkgshf@r.postjobfree.com

V.SANKARA NARAYANAN



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