Novartis is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies in the world, known for its focus on research and development in various therapeutic areas including oncology, cardiology, immunology, and neuroscience. Novartis produces a wide range of pharmaceuticals, including prescription drugs, generic drugs, vaccines, and over-the-counter medications. The company also has divisions dedicated to eye care and generic medicines. Novartis is recognized for its innovative drugs and contributions to healthcare globally.
Job Opening: Quality Manager – TRD
Job Description
Summary: We are seeking a Quality Manager for our TRD (Technical Research and Development) team. The ideal candidate will provide quality assurance with a focus on IT systems, offering guidance and support to operational activities within our development and research organizations. This role ensures compliance with applicable regulatory requirements, Novartis procedures, and quality standards. The Quality Manager will manage projects, including Quality Plan initiatives, and processes to support quality objectives and ensure compliance with GxP regulations.
Key Responsibilities:
TRD QA Manager as Business System Owner: Oversee the development, maintenance, integration, and operation of GXP-validated IT systems.
System Enhancements: Document, test, and implement operational requirements according to IT Waterfall Methodology.
Compliance and Security: Ensure the system and data security comply with Information Security and Compliance requirements.
System Upgrades: Identify and implement IT system upgrades to enhance performance and address recurrent application issues and bug fixes.
Interface Mitigation: Collaborate with other platforms (e.g., SAP, IRT) to address and mitigate interface-level issues.
Audit Support: Assist with internal audits and health authority inspections.
Deviation Remediation: Help remediate deviations related to IT systems and monitor associated corrective and preventive actions.
Validation Reports: Review and approve IT system validation reports.
Candidate Profile
Education: Bachelor’s or Master’s Degree in a related field.
Experience:
Over 9 years of practical experience in the chemical/pharmaceutical industry or more than 3 years of expertise in the field.
Experience in handling IT systems as a Key User, Super User, or System Owner.
Knowledge of the drug development process or quality assurance.
Skills:
Basic project management, organizational, and planning skills.
Familiarity with relevant regulations (e.g., GMP, HSE) and Novartis-specific standards.
Additional Information
Experience: 5+ years
Qualification: B.Pharm, M.Pharm
Location: Hyderabad
Industry Type: Pharma/Healthcare/Clinical Research
Division: Development
Business Unit: Innovative Medicines
End Date: 20th July 2024
Join us at Novartis, where your contributions will drive the development of groundbreaking medicines and contribute to a healthier future.
