Summary
About the Role
Major accountabilities:
- Preparation of protocols and associated reports (e.g device qualification)
- Training of laboratory personnel
- Participation of SOP authorship
- Support in preparation and implementation of regulatory inspections and audits
- OOx/Deviation handling and CAPA definition
- KPI trending
- Review and approval of analytical tests (analytical release). Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -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
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
- The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times: Timely and GMP-compliant analysis & documentation of the results.
- Error rate: Number of OOS (analysis errors) related to the number of analyses
- Individual performance is assessed using the PMP performance dialog together with the manager
Minimum Requirements:
- BSC or MSc in natural sciences with 4 years of relevant experience in Pharma/Manufacturing sector in analytical lab, or PhD with 2 years of experience.
- Continuous Learning, dealing With Ambiguity, decision Making Skills.
- Experience with Industry Standards and Quality Control (QC) Testing, laboratory Equipment, Quality Control Sampling, GMP.
- Fluent in both German and English, both written and spoken.
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
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €58.199,96 /year (on a full-time basis). The actual salary may be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
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? 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
Adjustments for Applicants with Disabilities
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
