摘要
About the Role
Major accountabilities:
- Qualification activities for laboratory equipment, from simple instruments to computerized systems.
- Change Management for laboratory equipment.
- Interfacing with laboratory and QA for equipment related issues/inquiries.
- Interfacing with IT for definition of firewall rules, operating systems and software permissions, etc.
- Technical audit trail review.
- Management of local projects, as well as leading local rollout of global projects related to QC equipment.
- Archival of systems as virtual machines and periodic testing
- Management of the inventory in SAP
- Involvement in assessments and investigations
- Update of procedures and forms.
- Assessment of pharmacopeias general chapters
- Participation to health authorities and customer audits as SME
Key performance indicators:
- Timely handling of deviations and other quality relevant tasks.
- Timely update of SOPs.
- Timely execution of trainings.
- Qualification of laboratory equipment according to plan defined with the stakeholders.
- No avoidable safety incidents.
- Project delivered according to predefined quality, scope, costs, and schedule.
Minimum Requirements:
Work Experience:
- Proven experience in the qualification and operation of computerized and non-computerized laboratory equipment under GMP.
- Good knowledge of analytical techniques.
- Being able to effectively communicate at a technical level with both laboratory and IT.
- Good IT knowledge (Windows permissions, active directory, networks, VMware virtual machines).
- Knowledge of CDS / LIMS
- Very good knowledge of GMP, GAMP and data integrity principles.
Skills:
- Be open to continuous learning.
- Proactive thinking and decision making.
- At least 5 y experience in GMP environment.
- Knowledge of laboratory equipment and operations in a laboratory.
- Smart risk taking.
Languages :
- English: very good in speaking and writing.
- German: very good in speaking and writing.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
