Senior Manager - IT Quality Amgen Technology Private Limited

10.0 - 15.0 years

10 - 15 Lacs

Hyderabad / Secunderabad, Telangana, Telangana, India

On-site

Senior Manager IT Quality Assurance Location: Hyderabad, India (Amgen India AIN) Work Type: On-site as per site policy Role Overview: This vital leadership role involves executing complex and novel IT QA assignments requiring strategic planning and innovative techniques. You will oversee GxP system reviews and risk assessments per Amgen's quality policies and regulatory standards. As Senior Manager, you will supervise and mentor staff across multiple IT QA workflows, with a focus on compliance, continuous improvement, and cross-functional collaboration. Focus Areas: Computer System Validation (CSV): In-depth knowledge of 21 CFR Part 11, EU Annex 11, and GAMP standards. Audit Trail and Period...

Posted 3 months ago

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