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Senior Executive/ Assistant Manager QA(QMS) for API Manufacturing Facility - Bidar

Senior Executive/ Assistant Manager QA(QMS) for API Manufacturing Facility - Bidar

Sai Life Sciences Ltd

0 years

0 Lacs

Bidar Karnataka India

Posted:2 weeks ago| Platform:

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Skills Required

api manufacturing initiation management controls risk assessment audits spec reports training support documentation

Work Mode

On-site

Job Type

Full Time

Job Description

Initiation, review and approval of all types of quality management systems (Ex: Change controls, Deviations, Investigations, CAPA, OOS, and Complaints etc.
Handling of Return Goods.
Handling of quality system and perform risk assessment to the required quality system.
Conduct regular internal audits as per the need basis.
Reviewing and approving of all documents (SOP’s, Spec & STPs, Forms, protocols and reports etc.)
Review of annual product quality review reports.
Providing training on all cGMP topics to employees at site.
Supporting to customer audits/ visits and regulatory audits.
Support to provide necessary documents for amendments, annual updates and regulatory filings and CMC supporting documentation.
Filling of questionnaires, declarations & quality agreements.
Execution of additional responsibilities assigned by HOD

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