Summary
About the Role
Key Responsibilities:
- Ensure QC activities executed according to cGxP standards.
- Collaboration in GxP audits/inspections.
- Ensure methods and procedures are up to date.
- Introduction of new technologies; drives implementation of new requirements.
- Statistics for decision making. Maintenance and calibration of equipment.
- Elaboration of the maintenance and calibration plan.
- Improvements in Analytical Methods • Product and process validations.
- Support validation and qualification with analysis. Process performance.
- Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements and supports a robust career path deployment and succession plan for area of responsibility
- Invest time in personally developing and coaching talents
- Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site
- Ensure overall inspection readiness for area of responsibility.
Essential Requirement:
- BS: 12+ years related experience with 5+ years in management
- Related experience should be in GMP-regulated industries in Quality Control.
- Must have a working knowledge of health authority and regulatory requirements as well as industry quality management tools, standards, and quality systems.
- Must have an understanding of pharmaceutical industry trends and practices.
- Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities
Desired Requirement:
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
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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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
