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Venkatesh Swamy
Pharma
Hyderabad,TG
Summary
Well-qualified professional with a master's degree in the area of Quality Assurance and currently working as Research Associate with commendable skills at Suven Lifesciences Limited from 2 year and 4 months background as data reviewer, handling of QMS and QA systems. Intelligent and enterprising professional always pursuing ways to streamline or optimize processes.
Overview
2
2
Languages
1
1
Certification
8
8
years of post-secondary education
2
2
years of professional experience
Work History
Research Associate
Suven Lifesciences Limited
Hyderabad, Telangana
05.2019 - Current
- Monitoring and handling of Formulation Analytical, Analytical, Bioanalytical Departments.
- Preparation, Implementation and monitoring of effective Quality Management System (QMS) procedures.
- Review of Standard Operating Procedures (SOP's).
- Involved in NABL, USFDA & EU QP Audits.
- Involved in Clinical Trails related meetings and discussions with CRO's of In-house IND and NDA products.
- Review of Calibration & performance verification data of instrument's / equipment's.
- Review of Method development and validation protocols and reports.
- Maintenance of Archives.
- Review of IND and NDA modules documents of Drug product and preparation of documents (eCTD format) as per regulatory requirements.
- Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
- Effective implementation of employee training program's
- Maintaining Good documentation practices
- Review of Formulation Development Lab note books, Analytical Records (Raw material Analytical records, packaging material analytical records).
- Responsible for overall Quality Assurance department activities and to co-ordinate Qualification / Validation of Equipment, Systems, Analytical techniques and Process.
- Investigation and review of Deviations, OOS, Change controls and Incidents.
- Review of calibration schedules and records.
- Review of trending data (Water, Temperature, environmental monitoring)
- Review of Specifications, Standard Test Procedures.
- Loading and Unloading of Stability samples.
- Reviewing of BMR's, BPR’s and Sampling protocols of Clinical batches.
- Review of IQ, OQ, PQ documents for related equipments / instruments
Education
M.Pharm (Pharmaceutical Quality Assurance) - Pharmacy
Manipal College of Pharmaceutical Sciences
Manipal, KA 08.2017 - 06.2019
Bachelor of Science - Pharmacy
Chalapathi Institute of Pharmaceutical Sciences
Guntur, Andhrapradesh 10.2013 - 04.2017
Intermediate - Bi.p.c
Sri Chaitanya College
Guntur, Andhrapradesh 01.2011 - 01.2013
SSC -
Kanna English Medium School
Guntur, Andhrapradesh 01.2010 - 01.2011
Skills
Documentation skills
Quality assurance controls
GxP
QMS
Regulatory
Audits
Internships
Worked as a project trainee in Formulation analytical R&D (FAR&D) from Jun-2018 to Dec-2018 in Aurobindo Pharma Limited (APL RC-II), Hyderabad.
Accomplishments
GPAT Qualified with an AIR 2032 in the year 2017.
NIPER JEE: AIR 381 in the year 2017
AP-PGCET: State 5th rank in the year 2017.
Software
Empower
Additional Information
Academic Activities:
- Offered my services as a NSS volunteer.
- Presented and bagged 1st prize for presenting the topic "Biohazards" at national level youth festival held at vignan college of pharmacy during the year 2015.
- Presented Poster on the topic "Estimation of Lactoferrin in raw and pasteurized milk sample by colorimetry" during INDO-GERMAN METABOLIC MEET (IGMM)-2017 conducted at Manipal Academy of Higher Education (MAHE).
- Participated in one week certificate course on intellectual property rights conducted by MAHE in association with Philips IP&Standards Organization at Manipal, during the year 2018.
Memberships:
- Student member in ISPOR-ANU chapter during the year 2013-2017.
- Worked as one of the associate editors in our college annual magazine "PRAXIS" during the year 2015-2016.
- Student member in the IPA LAM branch during the year 2016-2017.
- Worked as an active member of the Innovative communication Club (I2C) during the year 2018.
Certification
ISO/IEC 17025:2017
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Personal Information
Father's Name: Nageswara Rao Swamy
Mother's Name: Sujatha Swamy
Date of Birth: 09-Sep-1995
Address: D.No: 24-7-329, 1st lane, 2nd cross raod, ramanapeta, Guntur - 522007, Andhrapradesh.
Current Address: Block 3, 501, CBR estates, Madinaguda, Hyderabad - 500050, Telangana.
Blood Group: A +ve.
Quote
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Timeline
ISO/IEC 17025:2017
05-2020
Research Associate
Suven Lifesciences Limited
05.2019 - Current
M.Pharm (Pharmaceutical Quality Assurance) - Pharmacy
Manipal College of Pharmaceutical Sciences
08.2017 - 06.2019
Bachelor of Science - Pharmacy
Chalapathi Institute of Pharmaceutical Sciences
10.2013 - 04.2017
Intermediate - Bi.p.c
Sri Chaitanya College
01.2011 - 01.2013
SSC -
Kanna English Medium School
01.2010 - 01.2011