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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