Summary
Overview
Work History
Education
Skills
Timeline
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Namita Shrivastava

Namita Shrivastava

Assistant Manager (Q.A.)
New Delhi

Summary

  • Designated ISO 9001: 2008 Management Representative ensures pertinent regulatory and customer requirements through the development, implementation, and refinement of quality plans and systems.
  • Ability to effectively build and maintain relationships with multiple departments, RM Vendors in order to effectively solve problems.
  • Acquainted with the quality management cycle ,and corrective Action/Prevention Action (CAPA) processes.

Overview

8
8
years of professional experience

Work History

Assistant Manager of Quality Assurance

Corel Pharma Chem
03.2013 - 12.2020
  • Supported the development, implementation, maintenance, and oversight of a quality management system.
  • Supported the compilation of DMF / Dossier and submission of annual updates for DMF / Dossier (US and china).
  • Skilled in conducting professional patent searches using various free patent databases including USPTO, Espacenet, EPOLINE, WIPO, Patent-Lens, Patentscope, Scirus, and Google Patents.
  • Facilitated working groups to collaborate and write project-controlled documents as part of the quality management system: SOPs, Policies and Audit reports.
  • Stayed abreast with current ICH guidelines,GMP regulations.
  • Participated in oversight and management of external and Internal Audit with guidance from management.
  • Supported the development and reviewed GMP / ISO audit agendas, audit plans, audit reports, and CAPA's.
  • Participated in preparations for regulatory inspections, including reviewing Inspection Readiness Plans, Mock Inspections.
  • Review, track, and/or trends routine quality data Reported adverse trends to management with a remediation plan.
  • Assisted in resolving compliance issues at plant sites, and provide an assessment of the impact of any deficiencies.

Lecturer, Pharmaceutical Chemistry

Smriti College Of Pharmaceutical Education
07.2008 - 12.2010
  • My responsibilities include carrying out teaching and research duties, administering degree and postgraduate courses, organizing lectures, and supervising seminars.
  • As a research guide, I assist M Pharm and B Pharm students with their research projects.
  • Assessing students’ coursework and material.
  • Involved in the conduct of exams and the marking of results.
  • Coordinate with various industries to provide research facilities to the students.
  • Prepared course progress reports for review.

Officer (Drug Regulatory Affairs)

Mylan Laboratories Limited
07.2007 - 07.2008
  • "To ensure timely completion of new projects in Western Europe and the WHO market."
  • To review of approval package of registered products to ensure clearance of product specifications, product recipes & Art Work for commercial Execution.
  • Coordination in handling Responses to queries for WHO & European markets.
  • Review of Certificates of Analysis (CoA) for raw materials, in process, finished and packaging materials against Specifications.
  • Review & Approval of Batch manufacturing Record & Batch packaging Record of Exhibit & Commercial Batches.
  • Review of protocols & reports of exhibit batch and process validation.
  • Review of Batch Production Control Records.
  • Preparation of Annual Product Review.
  • Preparation and review of the Department’s Standard .Operating Procedures.
  • Undergoing Regulatory Audits and preparation of audit compliance reports.
  • Coordination for Book Keeping, Dossiers & Country Specific License etc.




Apprentice (Product Development Laboratory)

Ranbaxy Laboratories Limited
06.2004 - 06.2005
  • Coordination and follow-up with Production, Stability/QC department, and DRA for batch manufacturing, analysis (in-process bulk, finished product analysis, and stability studies), and filing of the product.
  • Preparation and Review of Process Validation Protocols and Reports.
  • Preparation and Review of Test Batch Monitoring Protocols and Reports.
  • Preparation and Review of Scale up Batch Protocols and Reports.
  • Execution of Scale up, Exhibit and Process Validation Batches.
  • Execution of sampling plan for Scale up, Exhibit and Process Validation Batches.
  • Preparation and review of Master Formula Card, Master Formula and Stability Protocol.

Education

Master of Pharmacy - Medicinal And Pharmaceutical Chemistry

Rajiv Gandhi Vishwavidyalaya
Bhopal
04.2001 -

Skills

Quality Management System

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Timeline

Assistant Manager of Quality Assurance

Corel Pharma Chem
03.2013 - 12.2020

Lecturer, Pharmaceutical Chemistry

Smriti College Of Pharmaceutical Education
07.2008 - 12.2010

Officer (Drug Regulatory Affairs)

Mylan Laboratories Limited
07.2007 - 07.2008

Apprentice (Product Development Laboratory)

Ranbaxy Laboratories Limited
06.2004 - 06.2005

Master of Pharmacy - Medicinal And Pharmaceutical Chemistry

Rajiv Gandhi Vishwavidyalaya
04.2001 -

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Namita ShrivastavaAssistant Manager (Q.A.)