Vishwajith V is seeking a position that leverages his skills and experience in quality assurance and quality control. He has over 8 years of experience in roles of increasing responsibility at companies like Hospira Healthcare India, Biocon Ltd, and SIMCON Laboratories. His experience includes remediation of training operations, handling deviations, CAPAs, audits, and in-process quality assurance. He has a M.Pharm degree focused on quality control and quality assurance. He is proficient in MS Office, statistical software like Minitab, and quality management systems. He also has experience in formulation development through internships and projects.
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Vishwajith
1. Vishwajith V
Irungattukottai, Chennai | +91 8754459990 | vvishwajith@gmail.com
OBJECTIVE
Seeking a position as a valued member of a team that could leverage my skills, energy and talent
for delivering value to the customer.
PROFESSIONAL EXPERIENCE
Senior Executive - Quality Remediation at Hospira Healthcare India Pvt Ltd. Chennai ,India. 06 Oct.2014
till date
Remediation of Training operations:
Inspection readiness- To understand and identify gaps in the training operation and bridging
the identified gaps.
Hands on exposure of ISOTrain application.
Regulatory audit- USFDA
Senior Executive - Quality Assurance at Biocon Ltd. Bangalore,India. 19 Sep.2011 30 Sep.2014
Quality Management Systems:
Handling of deviations- Login, Investigation and use of investigation tools like Ishikawa,
Control charts, 5Why system, 5Why 1H system.
Handling of CAPAs-Login, Assisting user departments in drawing CAPAs, Tracking of CAPAs,
and Evaluation of CAPA effectiveness.
Handling change management- Login, Review,Impact assessment, Approval/rejection.
Handling of In Process Quality Assurance of aseptic fill finish activity on weekends:
Line clearance, Monitoring of dispensing activities, Formulation, aseptic filtration and aseptic
filling and sealing of drug product.
Online and offline visual inspection process.
Monitoring of secondary packing activity involving labelling, carton coding, packing and
dispatch activities.
Issuance of batch records, packing and dispatch records.
Assisting in vendor management
Desktop review of vendor questionnaires.
Assisting in audit preparations and assisting in handling regulatory audits, customer audits and
audit compliance.
Regulatory audit- USFDA, ANVISA, DCGI.
Customer audits - Pfizer, Mylan Labs etc.
MOH audits-Malaysia, Columbia, Sudan, Malawi, Ukraine, Ethiopia etc.
Trainee intern at Biocon Ltd. 25 Apr. 2011 to 16 Sep.2011
Responsibilities of various departments and its functions.
Shop floor training in secondary packing.
Shop floor training on visual inspection process.
Working of AHUs.
Preparation of SOPs.
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2. Student intern at M/s Micro Advanced Research Centre 11 May 2010- 22 Feb. 2011
Project title: Formulation Development and Evaluation of Solid Dosage Forms Comprising Delayed
Release Pellets of a Proton Pump Inhibitor.
Stages in Design of Multi Unit Pellet System:
Pre-formulation studies of drug and excipients
Drug loading on sugar spheres and seal coating of drug layered pellets using alkalizing
agents followed by enteric coating of seal coated pellets.
Compression into tablets and film coating
Stability studies as per ICH guidelines
Learnings:
Hands on exposure to MUPS with Fluidised bed processor for pelletization, Use of Rapid mixer
granulator for granulation technique, tablet compression machine, tablet coating machine
and inprocess testing equipments at R and D.
Use of various excipients in the formulation of solid dosage form.
QC & QA Executive at SIMCON Laboratories Pvt. Ltd, Mangalore. 01 Jan.2009 31 May 2009
Sampling of raw materials and finished products, In-process quality control, Monitoring of
dispensing, batch charging (API addition) and GMP rounds.
Industrial Training at SIMCON Laboratories Pvt. Ltd, Mangalore 22 Oct.2008 - 10 Dec. 2008
Basics of liquid dosage form manufacturing.
Basic analytical techniques like use of UV spectrophotometer, Titrimetry.
Industrial training in AstraZeneca Pharma India Ltd. Bangalore 05 May 2008- 23 may 2008
Introduction to various departments and their workflow.
Material flow and product manufacturing Basic work flow.
EDUCATION
Course
School/College
(Affiliation
)
Year
Percent
(%)
Subjects
M.Pharm
JSS College of
Pharmacy, Mysore
(JSS University)
India
Apr.2011 81%
Quality control and Quality Assurance,
Advanced pharmaceutical techniques,
Modern analytical techniques,
Pharmaceutical technology and
Validation.
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3. B. Pharm
Srinivas College of
Pharmacy,
Mangalore
(RGUHS, Bangalore)
India
Dec.2008 71%
Pharmaceutics, Pharmaceutical
Chemistry, Medicinal chemistry,
Pharmacognosy, Pharmacology,
Human anatomy and physiology,
Pathophysiology, Microbiology,
Pharmaceutical biotechnology
PROFESSIONAL TRAINING
Facing audits effectively
Statistical quality control
Time management
Assertive communication
COMPUTER SKILLS
Proficient in MS Office and Internet Applications
Use of Minitab software
ISOTrain application
EXTRA CURRICULAR ACTIVITIES
Prepared and presented a paper on Spectrophotometric methods for the estimation of
Pramipexole dihydrochloride at APTICON-09 national convention held in Jodhpur. This
paper was published in World Journal of Chemistry in Dec. 2009.
http://idosi.org/wjc/4(2)09/11.pdf
Organized seminars and competitions during my tenure as the Academic Secretary of the
Students Council 2007-08.
Participated in NSS camps organized by the college and was the Student Editor of the College
Bulletin 2007-2009.
STRENGTHS
Energetic, Enthusiastic and hardworking.
Ability to communicate with people at all levels and capacity to manage with minimum
supervision.
Dependable and a team player with a positive attitude.
PERSONAL DETAILS
Date of birth : February 05, 1986
Marital status : Married
Address : #11, Mahalakshmi Avenue
Near Devi Academy School
Alapakkam, Chennai-600116
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