Quality Assurance Executive
SUVEN LIFE SCIENCES LTD AND MYLAN LABORATORIES LTD
Total years of experience :16 years, 8 Months
● Monitor the issues of Batch production records and formats .
● Review of all procedures and protocols prior to the approval from the Manager.
· Verifying the Warehouse documents like Inward register, D.Cs, Material Issue Records,
& Product related BIN Cards.
· Review the Batch Production Records, Cleaning procedures and operational procedures
for various equipments.
· Handling of Change Controls & Deviations and preparation of investigation reports.
· Handling of customer complaints.
· Handling of Incidents.
· Implementation of SOPs, covering the system to be implemented in different
departments.
· Participating Internal and External audits .
· Releasing or rejecting of all APIs and intermediates.
· Guide the Trainees in their regular activities.
· Daily plant & QC visits .
Validation, Change controls and Qualifications:
· Prospective, process and cleaning validations.
· Qualification : IQ.OQ and PQ
· Execution of the validation plans and qualification programme along with the concerned
personnel from R&D, Production, Quality Control and Engineering departments.
· Monitoring the process trends for the APIs with respect to quality parameters and
reviewing the actual performance with the standard / excepted results.
Preparation of Annual Reports:
· Preparation of Annual Review Reports, covering all the aspects, ranging from the
introduction of the new product
· Review of annual product reviews.
· Faced US FDA Audit and ISO 9001:2008, ISO 14001:2004, OHSAS 18001:2007 audits.