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About the Role
Location: Istanbul Kurtköy, Turkey #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities:
Using structured RCA (Root Cause Analysis) methodologies such as impact assessment, Fish bone diagram, 5 whys, Timeline & process mapping for investigation of deviations
Handling Investigations and Deviations related to Process (Upstream / Downstream), Product & Equipment
Understanding of core manufacturing unit operations such as sampling, monitoring, and continuous process support
Handling procedural requirements for HA audits
Responsible for offering technical and scientific expertise to address process-specific matters, ensuring compliance with cGMPs, SOPs (Standard Operating Procedures), and relevant guidelines and functional standards (such as HSE (Health, Safety and Environment) and NOSSCE)
Handling internal and health authority audits and inspections
Ensuring overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Essential Requirements:
Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Master´s degree is a plus
Min 8 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility
Minimum 5 years of experience with deviation management and investigation
Knowledge of risk assessment and risk management programs
Fluent English, German is a plus
Desirable Requirements:
Good communication, presentation and interpersonal skills
Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistica etc.)
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
