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Sai Life Sciences Ltd
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Assistant Manager QA

Assistant Manager QA

Sai Life Sciences Ltd

3 - 7 years

0 Lacs

bidar karnataka

Posted:21 hours ago| Platform: Shine logo

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Skills Required

deviations capa oos complaints sops forms protocols reports cgmp training customer audits regulatory audits documentation regulatory filings questionnaires declarations change controls investigations return goods risk assessments internal audits spec stps product quality review amendments cmc quality agreements

Work Mode

On-site

Job Type

Full Time

Job Description

As the Quality Management Systems Specialist, your role will involve initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. Additionally, 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 responsibilities. Key Responsibilities: - Initiate, review, and approve quality management systems including Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints - Handle Return Goods and perform risk assessments to ensure the proper functioning of the quality system - Conduct regular internal audits to maintain compliance - Review and approve all documents such as SOPs, Spec & STPs, Forms, protocols, and reports - Review annual product quality review reports and provide training on cGMP topics to site employees - Support customer audits/visits and regulatory audits - Provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation - Fill out questionnaires, declarations, and quality agreements - Execute any additional responsibilities assigned by the Head of Department Qualifications Required: - Bachelor's degree in a relevant field - Prior experience in quality management systems within the pharmaceutical industry - Strong knowledge of cGMP guidelines and regulatory requirements - Excellent attention to detail and organizational skills - Effective communication and interpersonal abilities Note: The company values continuous learning and development, providing opportunities for professional growth and advancement within the organization.,

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Assistant Manager QA