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Sai Life Sciences Ltd
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Assistant Manager QA

Assistant Manager QA

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. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

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