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How you’ll spend your day
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
Your experience and qualifications
7-12 years’ experience in API only
M.Sc. chemistry, B. Pharm, M. Pharm and B. tech chemical