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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:1 week 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

Role Overview: 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. Key Responsibilities: - Review and approve all documents including SOPs, Spec & STPs, Forms, protocols, and reports to ensure compliance. - Review annual product quality review reports and provide training on cGMP topics to employees at the site. - Support customer audits/visits and regulatory audits, as well as 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: - Previous experience in initiating, reviewing, and approving quality management systems. - Strong understanding of Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. - Ability to conduct risk assessments and internal audits effectively. - Knowledge of cGMP guidelines and compliance requirements. - Excellent communication skills for providing training and supporting audits. - Detail-oriented and able to handle multiple responsibilities effectively. (Note: No additional details of the company were mentioned in the job description),

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Assistant Manager QA