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amuthan amuthan, Manager QA

amuthan amuthan

Manager QA

Par Formulations Private Limited

Location
India
Education
Master's degree, QMS
Experience
19 years, 5 Months

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Work Experience

Total years of experience :19 years, 5 Months

Manager QA at Par Formulations Private Limited
  • India - Chennai
  • My current job since July 2011

Planning & Execution of activities related to Manufacturing QA for Exhibit (ANDA Submission) Batches and commercial batches. Review of regulatory dossiers

Junior Manager QA at Dr Reddy’s Lab
  • India - Hyderabad
  • September 2006 to July 2011

Skilled in Execution of ANDA Submission Batches & CPS (Custom Pharmaceutical Services) clinical trial Batches, commercial batches monitoring activity from Quality Assurance perspective.
Review & Approval of Master Production Records (Master BMR & BPR), Stability Protocol, Sampling Protocol

Senior Officer – QA at Grandix Pharmaceuticals Ltd, known as Actavis
  • India - Chennai
  • January 2005 to September 2006

Master BMR, BPR Review
SOP, MFR Preparation
Planning, & Execution of Validation activities

Education

Master's degree, QMS
  • at BITS
  • April 2009

M.Sc (Quality Management)

Master's degree, Chemistry
  • at MKU
  • January 2002

M.Sc. (Chemistry)

Specialties & Skills

ANDA
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Records
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Quality Systems
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Audit Support
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GMP
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QMS
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Audit and Compliance
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Submission documents review
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GMP
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validation
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Quality Assurance
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Languages

English
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