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srilatha
US
Manager Quality Assurance
Look forward for career in Quality assuarance in pharma and biotech industry
SNAPSHOT CURRICULUM VITAE
V.S.LATHA
e-mail id: srilathavs@rediffmail.com
OBJECTIVE: To develop a prospective career in the light of new developments and
emerging challenges in Quality Assurance in Biotech / pharmaceutical sector.
SUMMARY: Lively, committed, workaholic, successful candidate having total experience of 10 years in Reputed USFDA,MHRA, WHO(Geneva), MCC, Health Canada , Brazil – ANVISA, ISO approved Pharmaceutical and Bio-Pharmaceutical industries in the fields of Quality Control, Analytical Development and Quality Assurance. Thorough knowledge in Handling all the core Quality Assurance functions and Regulatory submissions, Audit compliance and Documentation concepts. Also handled submission to DCGI, RCGM and DCA for biotech products.
“ Strength Lies in giving value addition and focus on continuous improvement”
ACADEMIC PROFILE
M.Sc., B.Sc., PGDCAQM
INDUSTRY EXPERIENCE: 10 yrs
Dr.REDDY’S LABORATORIES LIMITED
SHANTHA BIOTECH LIMITED
AUROBINDO PHARMA LIMITED
BIOLOGICAL E. LIMITED
MAJOR ACHIEVEMENTS
1. Successful preparation and handled all the regulatory audits USFDA, MCC-South Africa, Brazil – ANVISA, MHRA – UK, Health Canada. Excellent planning , organising, gap analysis, timely action in preparation for audits. Dealt with the auditors one to one
during audits and successful..
2. Handled asceptic process validation, transport validation ,Stability studies and VVM validation
3. Prepared , Handled and achieved ISO 9001:2000 certification audit. It was upgradation from version 1994 to 2000. Effectively brought about the changes in the quality systems.
4. Prepared for , Participated and successful in the WHO (Geneva ) approval certification audit , one to one involvement with WHO auditors and handled all the Quality assurance and Documentation aspects. Given inputs and review of PSF filing of Hepatitis – B and successful.)
5. Designed electronic document control, Streamlined documentation system and modified the change control system.
6. Achieved product Registration and Company Registration in 20 countries
(Non regulated market) within short span and other 18 countries process initiated.
7. Developed SOP, Designed , strengthened and implemented training program successfully for all employees
7. Responsible for successful completion of the JE vaccine facility Design and establishment as per cGMP standards, Validation of utilities and equipments and took up the project of establishment of quality systems.
8. Successful technology transfer of vaccine project from external site to manufacturing site. Efficient implementation of policies for success of project from R&D to Clinical stage.
TRAINING AND SEMINARS
1. Developing innovative thinking skills
2. Development of testing methods of Packaging materials
3. Team work
4. Quality Management
5. CFR sub parts 210 & 211- .
6. ISO 9001-2000 version
7. Personality Development Workshop
8. Training of Trainers Workshop
9. Team Building Workshop
Other Information
1.Efficient in handling the given role and do value addition to it.
2. Knowledge of Computer Applications. 3. Good communication, planning , organizing and execution skills. 4. Proactive, ability to Lead a team and motivate people
5. Work in line with Customer focus- Internal and External.
Languages(Spoken and Written): English, Hindi, Telugu and Tamil
The details furnished by me are true and can be verified at any given time. If given an opportunity I
shall do my best to serve the organization.
Thanking you,
V.S.Latha
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