Summary
About the Role
Major Accountabilities:
- Support management of all analytical activities related to projects within in responsibility of AS&T group·
- Support Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance (support subject matter expert in health authority inspections) ·
- Single point of contact for internal and external clients and contract laboratories, if applicable.
- Support timely analytical implementation (Method Transfer and Method Validation) for (new) projects in the course of product transfers·
- Setup and monitoring of stability studies·
- Support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T·
- Support implementation of GMP requirements. Support compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents)
Key Performance Indicators:
- Stakeholder orientation and collaboration
- On time and accurately completion of deliverables as per the responsibilities delegated
- Efficiency and Productivity metrics
- Process improvements
- Quality Compliance
- Problem solving skills and Troubleshooting
- Data Integrity
- Regulatory requirements knowledge
- Project Management
- Communication skills
- Continuous Learning.
Minimum Requirements:
Education:
M.Pharm/ MBA / Engineering/equivalent from a reputed institute.
Basic awareness of GxP compliance requirements.
Languages:
English
Experiences:
Minimum 5-6 years’ experience in Quality Assurance, Quality Control, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ medical device/ expertise in Learning management system
Languages:
- English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
