Quality Control Pvt Ltd
Resume:
V.Sankara Narayanan
Mobile: 0-989*******, 093********~ E-mail:***********@*****.**.**
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 : ***********@*****.**.**
V.SANKARA NARAYANAN
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