1. Date: May, 7th , 2013
Subject: QA Specialist and Auditor ( Contract or Consultant )
To,
The Hiring Manager,
I am interested in the open position of QA Specialist.( Quality Systems in Pharmaceutical
Business )
I do have excellent experience in Quality Assurance in Pharmaceutical, Biological and Biotech
Industry.
I also do have hands on experience in QA Dept as specialist in the following areas:
2) QA Specialist and Auditor II. This includes
Customer Complaints and Document Control.
API Inspection and Batch records auditing.
Auditing for Deviation, OOS, CAPA, GMP, cGMP, SOPs, Regulatory Compliance, Validation
Reports – Writing of Customer Complaint Protocol, ( IQ, OQ, and PQ ), QC reports, ICH Guide
Lines and Total Quality System for Pharmaceuticals, API (CMC) while assuring Pharmaceutical
product Safety, Purity and Integrity as it purpoets.
I also have hands on experience in pharmaceutical manufacturing/packaging operations as per
FDA rules and regulations.
I also have experience in QA Customer Complaints handling and writing reports and final
protocol and documentation.
I have degree in BS in Chemistry and BS in Pharmaceuticals from University Department of
Chemical Technology, University of Bombay, India.
Before immigrating to USA during the year April,1976, I worked for Parke-Davis (I) division of
Warner Lambert in India for more than 10 years as Production Executive.
I am USA Citizen.
Thank you for your consideration.
Sincerely,
Manohar Patil.
215-362-5696