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Quality Manager – TRD

Company: Novartis
Location: Hyderabad, India
Job Type: Full-time
Industry: Pharma/Healthcare/Clinical Research
Division: Development
Business Unit: Innovative Medicines
Experience: 9+ years of practical experience in the chemical/pharmaceutical industry or > 3 years of experience in the field of expertise
Qualification: B.Pharm, M.Pharm
Application End Date: 20th July 2024

Key Responsibilities:

  • Act as the Business System Owner for IT applications responsible for the overall development, maintenance, integration, and operation of GXP validated systems.
  • Play a vital role in system enhancements to ensure operational requirements are documented, tested, and implemented as per IT Waterfall Methodology.
  • Serve as a single point of responsibility for the application, ensuring the system and data are secured as required by Information Security and Compliance requirements.
  • Identify IT system upgrades to enhance system performance and mitigate recurrent application issues/bug fixes.
  • Represent the application in integrated Landscape and work with other Platforms (i.e., SAP, IRT, etc.) for mitigation of issues at the interface level.
  • Support internal audits and health authority inspections.
  • Assist in the remediation of deviations related to IT systems, ensuring follow-up and monitoring of associated corrective and preventive actions.
  • Review and approve the IT system validation reports.

Candidate Profile:

  • Bachelor/Master’s Degree with experience in the Pharmaceutical Industry, specifically a GMP background.
  • 9+ years of practical experience in the chemical/pharmaceutical industry or > 3 years of experience in the field of expertise.
  • Working knowledge of the Drug Development process or QA.
  • Experience in handling IT systems as a Key User/Super User/System Owner.
  • Basic project management, good organization, and planning skills.
  • Knowledge of relevant regulations (e.g., GMP, HSE, etc.) and Novartis-specific standards.

Additional Information:

  • Experience: 5+ years
  • Location: Hyderabad

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Application Link

Novartis Hiring Quality Manager - TRD

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