Teva Quality Analyst - TAPI 

India, Uttar Pradesh 

812312414

• Review of all documentation (i.e. batch records, test results, deviation, LIR, OOS, CAPA, validation, COA, Change Controls, etc.) prior to disposition (release or rejection) of batch
• Review of executed document like batch record etc., and also to ensure on time compliance of errors/deviations identified (if any) & review of step-by-step performance and compliance to batch manufacturing and packaging record requirements and resolution of any errors/deviations identified
• 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 Process/documentation (i.e. Protocol/report) of reviewing effectiveness to determine the effectiveness of a corrective or preventive action. Involving in investigation and ensuring on time closure of the investigation and event with resolution including corrective and preventive actions along with effectiveness determination
• Initiating NTM to Senior Quality Unit Management, Operations, and other applicable functions for the purpose of expedited communication of critical quality/compliance related issues & ensuring Quality interface with internal and external customers when dealing with activities such as issue resolution, product information, or for movement of materials, products, or process from site to site
• Developing Process for observing, reviewing, and auditing operations activities in order to facilitate batch review and to assure compliance. Also, ensure self-availability on shop floor as per requirement i.e. support to investigation etc.
• Responsible for assuring/coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements. In addition, responsible to assure appropriate shipping instructions, coordinate/approve route validation and investigation of temperature excursions as required for materials, components, drug substance, and drug product
• Responsible for oversight and review of R&D product development & product tech transfer at the site and batch manufacture in GMP areas including resolution of deviations. Provide and ensuring support to Regulatory Affairs for Market Authorization (MA) application and maintenance
• Responsible for Collection, compilation, analysis, and review of all data (i.e. manufacturing, packaging, testing, sourcing, deviations, stability, and changes etc.) and information supporting to validation status of a product
• Responsible for Review of all documentation associated with the validation of the procedure(s) used to clean the equipment train for a product’s manufacturing and packaging process and cleaning verifications. This includes cleaning to remove active ingredients and cleaning agents
• Responsible for Review of all documentation including protocols and reports associated with the validation of a product’s manufacturing (and packaging process, if required) and continuous process verification (CPV). Assessment of stability requirements based on the type of validation

• 7-12 years’ experience in API only
• M.Sc. chemistry, B. Pharm, M. Pharm and B. tech chemical

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