Summary
The role is responsible for coordination and management of analytical equipment related activities as well as to provide scientific analytical Support. This includes the evaluation, development and validation of methods required for raw materials and finished products.
About the Role
Major accountabilities:
- Statistical analysis -Support transfer projects -Product and process validation support -Validation and qualification analytics -Method transfer -Implementation of new techniques/technologies -Method optimization -Equipment qualification -Equipment calibration -Equipment breakdown management -Implementation of new technologies -Preparation of equipment qualification plan -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
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Key performance indicators:
- No delay in registration and APR/PQR due to faulty stability study design -No critical delays in study start -Approved protocol available on time, prompt storage of stability samples -Stability Study reports and evaluation documents available on time; proper support for method transfer activities and other transfer projects -Timely evaluation and communication of transport temperature excursions -Additional KPIs as defined within the management team -Samples and associated documents are delivered to the laboratories on time
Essential Requirements:
- Sound technical & scientific knowledge of pharmaceutical/ chemical
- Analytics/QC/ equivalent
- Communication Skills
- Continuous Learning
- Dealing With Ambiguity
- Decision Making Skills
- Gxp
- Industry Standards
- Laboratory Equipment
- Laboratory Excellence
- Quality Control (Qc) Testing
- Quality Control Sampling
- Self-awareness
- Technological Expertise
- Total Quality Management
- English
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.
Novartis is unable to offer relocation support for this role: please only apply if this location is accesible for you.
Location: Istanbul Kurtköy, Turkey; #Hybrid
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.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No