Quality Assurance Specialist
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I am a pharma professional with around 10 years experience in Quality Assurance.I have worked in various roles for companies such as Sanofi, Teva and now currently for FDC India Limited.
I have a wide exposure in Quality Management Systems (Deviation handling, CAPA ,Change control , APQRs and Self Inspections).
I have exposure to SAP, LIMS ,Trackwise , Document management System, Glorya and eQMS ample logic System.
I am looking for opportunities in Ireland in the pharma Field.
I am having around 10 years experience in quality Assurance .
- Investigation of Deviations , non-conformance ,OOS and OOTs.
-Investigation of Market complaints.
-Assessment of change controls.
-Review of APQRs.
-CAPA review and its effectiveness
-Participation in Self Inspections
-Trending of Deviations and complaints.
Previous responsibility in Teva and Sanofi Include:
- In charge of PQR preparation and review at Teva Goa
-Batch documentation review and Batch release
- Executing process validation at manufacturing stage as per protocol
-Performing Cleaning Validation as per protocol.
-Executing pack validation as per protocol.
-Self inspection coordinator of Internal Audits at site
-Handling of Global Notification to Management and performing the risk assessment.
-Execution, review of Process performance qualification/Process Validation reports
-Preparation and review of Hold time Summary Reports.
- Review of executed Batch Manufacturing Records, Batch Packing Records .
-Handling of Change controls, participation in deviation investigation. .
-Line clearances in granulation, compression, coating, tablet inspection and packing areas.
-In process control checks in manufacturing as well as packing lines
-AQL checks of tablets.
-Sampling at various stages of manufacturing
-Issuance of Batch Manufacturing Records, Batch Packing Records .
I have completed my Masters in Pharmacy from Goa University (India).
