Rachi Shah is a highly qualified professional, who works in Pfizer main office of which is in 4. as a Technical and Scientific and Clinical Writer from 2016. Rachi has earned professional experience in more than eight positions at various companies. Rachi Shah went to the Northeastern University and received education from 2015 to 2017. Boston, Massachusetts is the area, where this professional was lastly known to settle. The professional's phone number and email can be easily accessed through this website by request.
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Rachi Shah
Last updated Jun 13, 2024
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Work History
Technical and Scientific and Clinical Writer
New York, NY
Assist with verification of data within regulatory documents or reports.
Support the bioprocess R&D teams in tracking document completion, data verification strategies and completion of ed...
from Sep 1, 2016
Regulatory Affairs Intern
55 Court St SUITE 330, Boston, MA 02108
Preparation of Regulatory Templates for CMC-IND, Clinical and Non-clinical toxicology , Pre-IND, Clinical protocols, Phase I, II, III, NDA, BLA, Regulatory forms - FDA Form 1571, 1572, 3674....
Jul 2016 — Sep 2016
R and D Executive
Quality control Management, Quality Assurance Management, Research and Development, Technical support to Marketing People, Assisting Production department, Technical training to freshers.
May 2011 — Aug 2015
Research and Development and Executive Officer
Preparing, revising and reviewing the GMP quality documents like SOP, BMR, MFR, Validation protocols and reports.
Involved in carrying out internal audits to ensure the procedures, SOPs an...
Apr 2014 — Aug 2015
Senior Qc and Qa Officer
Monitored and assisted Production runs in accordance with GMP compliance assurance.
Planning and execution of production batches keeping priority deadlines.
Performing Cell Culture Techni...
Apr 2013 — Mar 2014
Junior Quality Control and Quality Assurance Officer
Testing of Raw materials, stability testing, assay transfers, and final products in compliance with the SOPs for product release and validation.
Recorded observations and data in complianc...
May 2011 — Mar 2013
Research Project Experience
Gained knowledge about various aspects of manufacturing tablet and capsules, granulation, compression, coating, grinding, labelling and packaging of new drugs by visiting many Pharmaceutical...
May 2009 — May 2011
Education
2015 — 2017
2006 — 2011
2006 — 2011
2006 — 2009
Occupations
Apprentice
Writer
Bachelor of Liberal Arts
Student Worker
Skills
Quality Management
Live Recording
Iso 14971
Organic Synthesis
Matlab
Clinical Research
Market Research
Regulatory Affairs
Trackwise
Polymer Chemistry
Coatings
Ftir
Protocol
Nda
Pma
Safety Compliance
Cgmp Practices
Management
Glp
Cmc Regulatory Affairs
Nanotechnology
Powerpoint
Public Speaking
Sharepoint
Hplc
Gmp
Healthcare
Laboratory Information Management System
Team Leadership
Bla
Titration
Microsoft Office
Microsoft Excel
Risk Management
Gcp
Drug Development
Testing
Employee Training
Regulatory Submissions
Ctd
Corrective and Preventive Action
Documentation
Project Management
Quality Control
Research
Nmr Spectroscopy
Ind
Gc
Sap
Gas Chromatography
Surface Chemistry
Data Analysis
Business Development
Data Verification
Life Sciences
Standard Operating Procedure
Laboratory Safety
Quality Assurance
1H Nmr
Analytical Chemistry
Time Management
Ide
Global Document Management System
Polymer Science
Iso 13485
Cost Reduction Strategies
Spectroscopy
Ich Guidelines
Records Management
Medical Devices
Polymerization
Column Chromatography
Organic Chemistry
Biologics
Inorganic Chemistry
Interpersonal Skills
Formulation
Business Strategy
Social Services
Global Regulatory Compliance
Clinical Study Report
Fda
Vector Nti