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OFFICER

OFFICER

Hetero

5 - 9 years

0 Lacs

hyderabad telangana

Posted:3 days ago| Platform: Shine logo

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Skills Required

quality management change control deviation management incident management process validation cleaning validation quality management system apqr quality review meeting sop issuance regulatory inspections selfinspections

Work Mode

On-site

Job Type

Full Time

Job Description

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coordinating and overseeing Quality review meetings, as well as implementing and harmonizing the Quality Management system across all oral dosage form facilities. In this position, you will be in charge of issuing and controlling Critical Quality Attribute (CQA) Standard Operating Procedures (SOPs) for the respective formulation units. You will provide support for regulatory inspections in all formulation units within the Hetero group and conduct self-inspections to ensure compliance with quality standards. You will work closely with your supervisor and be ready to take on any additional responsibilities as assigned. Your role is crucial in maintaining and enhancing the quality standards that define our organization.,

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Hetero

Pharmaceuticals

Hyderabad

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