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| Teva Pharmaceuticals Mumbai Job For B. Pharm/ M.Pharm/ MSc(Science)/B.S. Sciences - Quality Analyst |
Designation: Quality Analyst III
Work Location: Mumbai, IN, 400063
Company: Teva Pharmaceuticals
Qualifications
B. Pharm, / M. Pharm / M.Sc. (Science), B.S. Sciences.
Function: Quality
Job Description
Job Purpose is To manage the TPO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirements
Batch record review and disposition in global system like SAP etc.
Responsible to follow the Quality Management System of TPO organization, which is relevant to the job function
Provide impact assessment and risk assessment for impacted CMOs, to the Regional NTM Coordinator for the GNTMs issued, after coordinating with all CMOs
Batch record Review & Release
Generation of the Trackwise reports for deviations and change controls required for batch release. Review and ensure that there are no open deviations and change controls impacting the release of the batches.
Review of the temperature reports down loaded from temperature recorders.
If unsatisfactory result / temperature excursion forward to the investigation team for logging the deviation in the Trackwise and ensure completion before release.
Change Controls : Life cycle management of change control in Global Trackwise system
Initiate change controls related to the batch manufacturing and packing records specifications and analytical method of analysis stability protocols that are received from the CMOs
Evaluate the change controls for adequacy and perform line by line review of the documents QC SME for change controls that need analytical evaluation.
Review the method validation/verifications and method transfer reports associated with the change
Review process validation/qualification and other associated supporting documents required with the change
Experience Required : Minimum 6 - 8 years of experience in pharmaceutical industry ,Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing supply chain environment . Knowledge on Compliance Standards and Regulation as applicable to the market , Experience of handling Operational Quality QA/QC exposure and External / Contract manufacturing site
Experience Preferred : Knowledge and working experience with USFDA / EU and other competent authority approved sites
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