Summary
In this role you will be executing and managing process validation activities for aseptic products (fill&finish) and support preparation of various technical documentation packages (protocols, reports, technical assessments) in highest quality and given timelines.
About the Role
Location: Istanbul Kurtköy, Turkey; Warsaw, Poland; Mengeš, Slovenia #Hybrid
Key Responsibilities:
- Support maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
- Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
- Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready.
- Support site validation planning by writing and maintaining plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
- Author and review process validation protocols & reports, ongoing process protocols & reports.
- Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
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Essential Requirements:
- University degree in Chemistry, Pharmacy, Biotechnology, Pharmaceutical Technology or equivalent
- 5 years of experience with validations in the aseptics manufacturing in the pharmaceutical industry
- Fluent in English, German is a plus
- Great communication skills as well as experience in writing technical reports
- Proven understanding of quality systems and regulatory requirements across multiple health authorities.
- Collaborative mindset and problem solving skills with a high degree of flexibility
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
Benefits and Rewards:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
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.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
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
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
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
Division
Operations
Business Unit
Innovative Medicines
Location
Türkiye
Site
İstanbul Kurtköy
Company / Legal Entity
TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.
Alternative Location 1
Mengeš, Slovenia
Alternative Location 2
Warsaw, Poland
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regulär
Shift Work
No