Ranvijay Singh
Ahmedabad,Gujarat
Summary
Dear Hiring Manager,
I am writing to express my interest in the Quality Assurance Manager position in your
organization. I am confident that my 16 years of experience in Quality Assurance, including
Operational QA, QMS, Qualification, change management, CAPA, Quality Risk Management,
Investigation, OOS/OOT/LIR, Deviation, Digitization, Audit and Compliance, Lab compliance,
ANDA submissions, several successful USFDA and other regulatory inspections experience make
me a strong candidate for the role.
I work at Zydus Lifescience Ltd. as Associate Manager-QA, Overseeing QA SME. I manage
Quality operations, ensure regulatory compliance, and lead successful product-related
inspections by regulators such as MHRA, EU GMP, WHO, and USFDA.
As a Postgraduate, M.Sc. from KNPG College Gyanpur UP affiliated with Purvanchal University, I
aspire to contribute to the development of your organization and fulfill my responsibilities with
utmost dedication.
I am confident that I can add value to your organization and am available for an interview at
your convenience. Thank you for considering my application.
Thanking you in anticipation. in Quality Assurance/CQA in a growth-oriented
organization; preferably in Pharma/Biotech industry.
To obtain a challenging position as a QA Management in the pharmaceutical/Boitech industry,
leveraging my expertise in quality assurance, compliance, and performance management to
ensure the highest levels of product quality, regulatory compliance, and customer satisfaction.
Strong knowledge of regulatory requirements.
Leadership and team management.
Overview
19
19
years of professional experience
Work History
Associate Manager-QA
M/S Zydus Lifesciences Ltd
Ahmedabad
01.2017 - Current
- Quality systems management
- Continuous improvement mindset
- Communication and collaboration
- Analytical and problem-solving skills, and US-FDA approved unit from Sep
Sr. Executive
M/S Sun pharmaceuticals Industries Ltd
09.2012 - 09.2017
- A MHRA, TGA, and
- N-Visa approved unit from
Quality Control Executive
Lupin Limited
Indore , India
03.2011 - 09.2012
- Pithampur Indore
- A US-FDA, MHRA, and TGA approved unit from March 2011 to 20
Quality Control officer
M/S Ranbaxy Laboratories Ltd
Mohali , India
10.2008 - 03.2011
- US-FDA, TGA,
- MHRAapproved unit in Mohali
Quality Control officer
M/S Akums Drug's & Pharmaceuticals Ltd
03.2007 - 10.2007
- M.Sc
- (Chemistry) From KNPG college Gyanpur UP Affiliated to Purvanchal University UP
Skills
- IT Skills:
- Qualification of laboratory software
- Performance Qualification of LIMS
- Trackwise SME
- Lerner Management System (LMS), SABA
- Document compliance Manager (DCM)
- Novatech, Zytims, Documentum (D3), etc
- LIMS of Caliber and Ossasis with paperless technique (E-work sheet)
- SAP
- Tableau and Amplelogic for trend analysis
Timeline
Associate Manager-QA
M/S Zydus Lifesciences Ltd
01.2017 - Current
Sr. Executive
M/S Sun pharmaceuticals Industries Ltd
09.2012 - 09.2017
Quality Control Executive
Lupin Limited
03.2011 - 09.2012
Quality Control officer
M/S Ranbaxy Laboratories Ltd
10.2008 - 03.2011
Quality Control officer
M/S Akums Drug's & Pharmaceuticals Ltd
03.2007 - 10.2007