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Teva Quality Specialist III - QA- TAPI India, Madhya Pradesh, Gwalior 433813413
25.03.2025
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How you’ll spend your day
- Ensure on time dispatch related activity like verification of any deviation/OOS/LIR and other related QMS elements in the batch or its batch train.
- Ensure Review of all documentation (i.e. batch records, test results, deviation, LIR, OOS, CAPA, validation, COA, Change Controls, etc.) and perform disposition (release/rejection) of batches.
- Ensure review of executed document like batch record, analytical data etc. and to ensure on time compliance of error/deviations identified (if any).
- Monitoring and follow-up of corrective and preventive actions (review, approval, and on time closure of the CAPA) in order to resolve an event.
- Review and approval Process / documentation (i.e. Protocol/report) of reviewing effectiveness to determine the effectiveness of a corrective or preventive action.
- Involving in investigation, Review, and ensuring on time closure of the investigation with resolution including corrective and preventive actions along with effectiveness determination.
- Responsible for assuring / coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements.
Your experience and qualifications
- Required B.Sc./ M.Sc. qualified candidate
- 3 to 4 years relevant experience
- Hands on experience in batch disposition, Batch card review and Batch Release
- Basic Knowledge about Deviation / OOS Investigation
- Audit experience of USFDA / EDQM / EMA / TGA / PMDA. At least involved in any of the foreign regulatory Inspection
- Experience in ERP, TrackWise & LIMS system
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