Assistant Manager QA Sai Life Sciences Ltd
Sai Life Sciences Ltd
Office Location
Full Time
Experience: 5 - 5 years required
Pay:
Salary Information not included
Type: Full Time
Location: Bidar
Skills: 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
About Sai Life Sciences Ltd
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.,