This document is a resume for Venkataramani Swaminathan summarizing his experience and qualifications for quality assurance roles in pharmaceuticals and biotechnology. He has nearly 3 years of experience in quality assurance and control and is currently a Quality Assurance Senior Executive at Future Consumer Enterprises Ltd. He has a Masters in Biotechnology and Bioinformatics from La Trobe University in Australia and experience in quality assurance, auditing, documentation, and ensuring compliance with GMP and other standards at multiple companies.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
Based in Southern California, Pyramid Laboratories, Inc., fulfills contracted parenteral drug product manufacturing and analytical services assignments for clients spanning the biotech and pharmaceutical sectors. In June 2016, Pyramid Laboratories, Inc., announced the successful completion of a Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMP) audit spanning lab and manufacturing facilities.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
Based in Southern California, Pyramid Laboratories, Inc., fulfills contracted parenteral drug product manufacturing and analytical services assignments for clients spanning the biotech and pharmaceutical sectors. In June 2016, Pyramid Laboratories, Inc., announced the successful completion of a Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMP) audit spanning lab and manufacturing facilities.
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I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
1. SWAMINATHAN E-Mail: swaminav@gmail.com
VENKATARAMANI Phone: +91-7259573962 / +91-9176794572
Result-oriented professional targeting assignments in Quality Assurance &Control, preferably in
Pharmaceuticals/Biotechnology /Food Processing sector
P R O F I L E S U M M A R Y
• Offering nearly 3 years of experience in Quality Assurance & Control
• Currently associated with Future Consumer Enterprises Ltd., Tumkur as Quality Assurance Senior Executive
• Completed Masters of Biotechnology & Bioinformatics from La Trobe University, Melbourne, Australia in 2012
• In-depth knowledge of GHP & GMP and various quality standards and competency in
implementation of the same
• Proficient in developing & streamlining systems to enhance operational effectiveness
and meet goals within the cost, time & quality parameters
• Proficiency in maintaining reports pertaining to non-conformance of products or
processes
• An effective communicator, team player & quick learner with capabilities to analyse
& interpret unique problems, brings logical thinking to find the right solutions
C O R E C O M P E T E N C I E S
Quality Control/Assurance CAPA Process Improvement
Resource Management Team Management MIS Documentation
Regulatory Affairs Liaison & Coordination Auditing
O R G A N I S A T I O N A L E X P E R I E N C E
Since Feb’15 Future Consumer Enterprises Ltd., Tumkur, Karnataka
Quality Assurance Senior Executive
Key Result Areas:
• Reviewing SOPs, GMP documentation, line clearances, status control of raw materials and finish
product, participating in internal audits and retrieving and auditing on-site record documentation
• Performing critical phase inspections related to GMP manufacturing, and/or GCP and/or GLP studies
• Single-handedly working in the pulping line, doing analysis of the product for pH, Brix, Acidity & other parameters
• Writing and reviewing detailed documents explaining about the work and its results in terms of product purity
• Experiencing audit from external companies and by Indian government (IL & FS)
• Managing projects for ready-to-eat products which included making Indian snacks (like Samosa, Spring Roll, Paratha &
others) in industrial scale
• Conducting validation, stability studies, quality audits &
facility upgradation as per the requirements of regulated
market; taking various initiatives for optimization in
coordination with teams
• Developing methods and validating analytical systems i.e.
rigorous testing of methods for ensuring that they are precise,
accurate, reproducible, fool-proof & specific to the product
Highlights:
• Prepared new SOPs and manual
• Introduced the system for quality check
2. Symmetrix Biotech Private Ltd., Chandigarh (Nov’13-Jan’15)
Quality Assurance Associate
Key Result Areas:
• Worked as Associate Staff Scientist in the R & D
Division
• Quality Assurance: Making SOPs and Logbooks,
Issuing documents, Have knowledge of ICH-GMP and
making deviation report for production of Clot Specific
Streptokinase
• Functioned on Water Ultrafiltration System, Reverse
Osmosis (RO) and EDI Elix-100 water purification
system
• Worked in separation of blood components (like: Serum and Plasma) during clinical trials of our investigational drug
Elder Pharmaceuticals Ltd., Navi Mumbai (Mar’13-Oct’13)
Biotechnology Trainee (QA)
Key Result Areas:
• Steered the responsibility of:
o Finding cost effective methods to produce conjugated estrogens
o Analysis opportunity to gain working knowledge of COAs, writing SOPs and logbooks
A C A D E M I C P R O J E C T S
Year: 2010
Department: Department of Primary Industries (DPI) - Victorian AgriBiosciences Centre, Melbourne, Australia.
Description: Learnt different file formats such as BED, GFF, FFF, GTF & others by which the data was uploaded
in the GBrowse genome browser; identified snps and comparison of two DNA
sequences.
Year: 2009
Institute: Institute of Clinical Research (India) Bangalore, India
Description: Worked on doing a meta-analysis on drug-induced hepatotoxicity.
A C A D E M I C D E T A I L S
2012 Masters of Biotechnology & Bioinformatics from La Trobe University, Melbourne, Australia, Victoria
2009 PGDM in Clinical Research (PGDACR) from Institute of Clinical Research, Bangalore
2008 B.Tech. (Bioinformatics) from Padmashree Dr. D.Y. Patil Institute of Biotechnology and
Bioinformatics, Mumbai
I N T E R N S H I P
Year: 2008
Organization: Avesthagen (Avestha Gengraine Technologies Limited), Bangalore
3. Description: Worked on annotating five papers for prostate and breast cancer determining the biomarkers
which are responsible for the disease; learnt and constructed a general feature format (GFF) file
required to upload the data where biomarkers arepresent in the particular chromosome.
O T H E R C O U R S E S
• Completed FDA Smart ink course from FDA regarding FDA approval process by Dr.Joshua Sharlin in 2009
S E M I N A R S A T T E N D E D
• Computational drug discovery from Schrodinger Institute, Germany in NM University
P E R S O N A L D E T A I L S
Date of Birth: 24th
April 1987
Languages Known: English, Hindi & Tamil