Quality Operations Specialist at Novartis, Apply online!
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Job ID: REQ-10035539
Date: Jan 05, 2025
Location: India
Summary Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners.
About the Role: Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners.
Major Accountabilities Common Accountabilities (Applicable to all service teams)
- Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
- Hold accounts in workflow applications to ensure appropriate execution of service deliverables.
- Generate and analyze reports in various applications and perform follow-up actions if required.
- Escalate service-related issues and ensure timely investigation and compliance with procedures.
- Ensure compliance with internal quality standards, regulatory requirements, and service level agreements.
- Assist in ad hoc administrative activities as per business requirements.
Key Performance Indicators
- Extract data from relevant sources.
- Interpret and compile external supplier APQR data.
- Collect contributory reports for product evaluations.
- Support in updating and maintenance of APQR schedule.
Education Background
- M.Pharm/ MBA / Engineering/equivalent from a reputed institute.
- Min 1 yr Experience in Quality Assurance or Regulatory.
- Basic awareness of GxP compliance requirements.
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Keywords: Novartis, specialist quality operations, job posting, compliance, GxP, quality management system, Quality Operations Specialist
