摘要
Role Purpose:
Specialist in the area of analytics, supporting the laboratory team with in-depth knowledge to ensure efficient performance of laboratory activities and related investigations in compliance with GxP and HSE guidelines. Performs review and approval of analytical data.
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.
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? http://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: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
