Aragen is a trusted R&D and manufacturing partner to the global life sciences industry. From concept to commercial, we transform your ideas into solutions for better health. Whether large pharma or biotech, an agrochemical or animal health company, we provide you global resources and proven capabilities at every stage of the biopharma lifecycle, in small and large molecules. Our ability to offer end-to-end solutions or support standalone programs is underpinned by an innovation mindset, enabling technologies, and a partnership approach to every engagement.
Post : Dy. Manager / Manager - Quality Assurance (Formulation - OSD)
Role
1. Developing, implementing, and maintaining the Quality Management System and monitoring of its effectiveness.
2. Responsible to ensure issuance and control of Standard Operating Procedures, maintenance of the Site Master File.
3. Monitoring day to day activities of assigned jobs to the team and providing inputs to resolve the discrepancies in order to maintain appropriate quality systems
4. Responsible for provide training in all aspects of Quality Management Systems and GMP including procedural updates.
5. Responsible to Handling and closure of Quality Notifications
6. Responsible for supporting quality related customer complaint investigations and trending activities
7. Responsible for review and approval of Quality related documents
8. Responsible for approval of Analytical methods, validation documentation
9. Responsible for reviewing of Certificate of Analysis (CoA)
10. Responsible for Document control (records storage are secured to protect confidentiality under restricted access control to authorized personnel).
11. Managing the Empower software as a QA admin.
Qualification : M.Pharmacy /M.Sc
Work Experience : 9-12 Years
Interested can send across your updated resume with compensation details on rakesh.maganti@aragen.com
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