About the Role
Role Responsibilities:
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
- Support sample planning and sampling execution
- Stability testing (projects) – protocol preparation, evaluation, report preparation
- 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
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 Desirable 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)
- 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
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Role Requirements
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
