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Amneal Pharmaceuticals
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Senior Executive - QA

Senior Executive - QA

Amneal Pharmaceuticals

5 - 9 years

0 Lacs

ahmedabad gujarat

Posted:1 week ago| Platform: Shine logo

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Skills Required

verification protocols specifications root cause analysis capa trend analysis urs dq standard operating procedures process validation risk assessment bsc msc document handling batch manufacturing records batch packaging records layouts method of analysis logbooks change control procedure validation qualification protocol validation requalification validation activity qualification activity media fill hold time protocol cleaning verification bpharm mpharm

Work Mode

On-site

Job Type

Full Time

Job Description

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.,

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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Senior Executive - QA