PHARMACEUTICAL QUALITY ASSURANCE & REGULATORY AFFAIRS

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Resume ID:

612436

Location:

KOLKATA 

Category:

Engineering & Sciences, Manufacturing & Distribution, Medical, Dental & Healthcare Services, Other

Desired Salary:

$75,000.00 per year
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Resume Views:

8

Postal Code:

N5P 4L1

Employment Type:

Full Time, Permanent

Posted:

04.04.2018
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Objective:

To succeed in an environment of growth and excellence and earn a job which provides me self development and help me achieve personal as well as organization goal.
 

Education:

11.23.2015 - 11.29.2019
Symbiosis Centre For Distance Learning
Pursuing PGDBA – Operational Management


04.16.2012 - 06.17.2013
Bioinformatics Institute of India
Certificate in Intellectual Property Rights (Industry Program)
Certification


08.18.2008 - 10.06.2010
Roland Institute of Pharmaceutical Sciences
M. Pharm (Pharmaceutical Analysis & Quality Assurance)
Master’s Degree


04.19.2004 - 06.21.2008
Institute of Pharmacy & Technology
B. Pharm
Bachelor’s Degree


Work Experience:

01.19.2015 - 07.31.2015
Associate - Regulatory Affairs
Trans Integra Health Care Pvt. Ltd. | Pharmaceutical
  • Preparation/review & submission of regulatory documents
  • Liaising with regulatory authorities


05.02.2014 - 01.07.2015
Officer – Quality Assurance (Documentation)
Olive Health Care | Pharmaceutical
  • Preparation/review of MFR, BPCR, Batch Packaging Record, Finished Product Specification
  • Issuing, retrieval & archival of Documents
  • Handling on The Job trainings
  • Knowledge about Change control, OOS, Deviation, Incident, CAPA, Qualification Documents and Cleaning validation


09.05.2012 - 09.16.2013
Management Trainee - Plant Operations
Amra Remedies Ltd. | Pharmaceutical
  • Preparation of Quality Manuals
  • Documentation
  • Equipment Qualifications
  • Implementation of ISO 9001:2008


Skills:

  • Preparation/review of MFR, BPCR, Batch Packaging Record, Finished Product Specification
  • Issuing, retrieval & archival of Documents
  • Handling on The Job trainings
  • Knowledge about Change control, OOS, Deviation, Incident, CAPA, Qualification Documents and Cleaning validation
  • Preparation/review & submission of regulatory documents
  • Liaising with regulatory authorities
  • Preparation of Quality Manuals
  • Documentation
  • Equipment Qualifications
  • Implementation of ISO 9001:2008

Occupations:

Legal: Regulatory-Compliance Law
Medical-Health: Healthcare Aid
Quality Assurance-Safety: Food Safety and Inspection, General-Other: Quality Assurance-Safety, ISO Certification
User Info

RAKESH NAIR
KOLKATA, India

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