摘要
About the Role
Major accountabilities:
Operational
- OOx/deviation handling
- CAPA definition
- KPI trending
- Ensure all activities in compliance with cGxP, incl. data integrity
- Review and approval of analytical data / tests (analytical release)
- Maintain and calibrate equipment incl. plan preparation
- Finish relate physical and chemical testing (pH, UPLC, TLC, dose calibration)
- Trending and analysis of KPI/KQI
- Support sample planning and sampling execution
- Stability (when not centralized)
- Stability testing (projects) – protocol preparation, evaluation, report preparation
- Reporting (stability plan preparation, trend analysis, evaluation)
- Performance of stability studies, protocols and comparative reports for supplier qualification
- Review and approval of analytical tests (analytical release)
HSE
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Participate in HSE risk assessments
- Preparation and participation to internal HSE audits
- Responsible for participating in initial training and retraining
Key Performance Indicators
- Analytical lead times
- Timely and GMP-compliant analysis and documentation of the results
- Error rate: Number of OOS (analysis errors) related to the number of analyzes
- No complaints about official inspections
Ideal Background
Relevant Experience
- Professional experience (3-5 years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent; Collaborating across boundaries; Functional Breadth; efficient inter and intra-departmental communications.
Education & Qualification
- Technical education & 3-5 years relevant experience or
- University degree in Pharmacy or Chemistry or equivalent + 0-4 years working experience
Languages
Good (oral and written) in English; fluent in local language (oral and written)
Competencies
- Collaboration; result-oriented
- Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
- MS Office applications and other standard IT applications supporting Quality activities
- Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
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
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
