Senior Executive - QA Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

The role involves handling document issuance, distribution, and retrieval, including verification of various documents such as Batch Manufacturing records, Protocols, layouts, specifications, etc. Issuing approved Standard Formats and Logbooks to User Departments, as well as managing line-clearance checklists, interventions checklist, and BMR/BPR pages. Additionally, handling proposed changes per the change control procedure, assessing associated risks/impacts, and ensuring the implementation of action plans. Conducting investigations using root cause analysis tools, performing additional studies, and deriving appropriate CAPA. Managing recommended CAPA and evaluating the implementation of recommended actions. Performing trend analysis on deviations, change controls, complaints, etc., to identify repetitive events for further evaluation and CAPA. Reviewing URS, DQ, and vendor/supplier documents related to qualification. Preparing and reviewing Validation/Qualification protocols and reports. Executing and reviewing Qualification/Validation activities of Equipment/System/Facility and Plant utilities, coordinating with relevant departments for timely completion. Preparing and reviewing media fill and hold time protocols and reports, as well as Standard Operating Procedures for the Quality Assurance Department. Assessing Change Control, Deviation, CAPA, Investigations, and preparing protocols for process validation and cleaning verification/validation. Conducting sampling activities as per protocols and managing risk assessment activities related to equipment/process/facility/system. The ideal candidate should have a B.Sc/M.Sc/B.Pharm/M.Pharm degree.,

Posted 1 week ago

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