תקציר
About the Role
Major Accountabilities:
- Sample storage and management
- Analytical testing/documentation of drug product / finished product / complaints / stability / packaging material samples to GxP standards Stability
- Testing/Sample storage and management .
- Analytical documentation of stability samples to GxP standards
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
Key Performance Indicators:
- Orders are processed correctly and quickly.
- No waiting times due to wrong or delayed order.
- Deadline adherence rate: orders completed on time, all missed deadlines reported in good time, the shortest possible lead time
- Ensure constant readiness for inspection, no critical complaints from superiors and inspectors
- Consistently follow the GMP and GSU guidelines, as well as the SOPs, no critical irregularities
- Finding and implementing optimization options to reduce costs
- Completed training plan
Work Experience:
- Analytical Validation
- Good Manufacturing Practices (cGMP)
- Audit & Inspection Management
- Quality Control
- Quality Management Systems
- Technological Expertise
- Stability Testing (Pharmaceutical) Management
- Technological Expertise
- Laboratory Excellence
- SOP (Standard Operation Procedure) Management
- Complaints Management
- Documentation Management
- Quality Compliance
Skills:
- Deadline Adherence
- Dealing With Ambiguity
- Decision Making
- Collaboration
- Regulatory requirements knowledge
- Problem Solving Skills
- Leadership
- Communication skills
- Data Integrity
- Digital saviness
Languages:
- English.
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: Learn about all the ways we’ll help you thrive personally and professionally.
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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.