Quality Assurance auditor
Resume:
Company : - Interpharm Inc., Hauppauge, NY-*****
Designation : - Q.A. Auditing Specialist (chemist)
Report to : - Q.A. Supervisor
Starting Date : - 24 January 2007
Present Salary : - 38000/Year
Work profile: -
? To issue, review and maintain of Master Production record, Packaging order record and controlled log books.
? Evaluate and/or initiate Standard Operating Procedures.
? Improve and maintain the internal Audit program.
? Tracking and trending of out of specification results, failure investigation, deviations, change controls, complaints review, recalls or field alerts.
? Periodic monitoring and verification of operations to ensure compliance to written procedures and/or regulatory requirement.
? Provide training, as needed, and keeps track of individual training needs, including follow-up with department heads or supervisors.
? Release a production batch in the “Ross system” from manufacturing to packaging to shipping.
? To review new product validation and submission batch.
? Monitoring and enforcing cGMP/GLP compliance within the manufacturing plant.
? Investigation for corrective and preventive action needed to address audit observations and/or discrepancies.
? Monitoring rejection and discrepancy report and performing trend analysis.
? Assisting Auditing supervisor with the development of new and revised SOP.
? Collect, Maintain and enter the APR data in Annual product review software system.(Lotus Smart suite 9.8.1 revision 6.5)
? Prepare the APR data file of all products and coordinate with each department to receive the data within appropriate time.
? Maintain and verify cleaning procedure and related document entry in plant.
Other Knowledge:-
? I have knowledge about to operate Vankel friabilator, Disintegrator, Hardness tester and Mettlel Toledo weight variation tester.
? I have good knowledge of MS Office.
Project Involvement: -
? I was involved in the project to collect, evaluate and made a spread sheet of resin, colorant and liner used in packaging component during the year 2003 to 2007. These data is then compared with ANDA report.
? To investigate that moisture content, friability, bottle head space, plays an active role in broken tablets customer complaints and makes a protocol of broken tablets customer complaints.
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