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Global Regulatory, RWE & Medical (2RM) Quality Operations Manager Opella

5.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

As a Global Regulatory, RWE & Medical (2RM) Quality Operations Manager at Opella, your role involves supporting the Global Regulatory, RWE, and Medical teams by implementing and maintaining Quality Systems to ensure that activities are conducted and data are generated, documented, and reported in compliance with GxP requirements. Key Responsibilities: - Event & CAPA: - Perform QA assessment, root cause analysis, and investigation report - Review and approve closure of CAPA - Ensure timely closure of investigations and CAPAs - Escalate risks to 2RM Lead and manager as required - Change control: - Create Change Control as per 2RM Quality Lead assessment - Coordinate until Change Control closur...

Posted 4 weeks ago

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