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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

5 - 9 years

0 Lacs

bidar karnataka

Posted:1 week ago| Platform: Shine logo

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Skills Required

deviations capa oos complaints risk assessment document review training cgmp customer audits regulatory audits regulatory filings questionnaires quality management systems change controls investigations return goods handling internal audits product quality review amendments cmc documentation quality agreements

Work Mode

On-site

Job Type

Full Time

Job Description

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

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