摘要
About the Role
Major Accountabilities:
- Coordinate and support the Quality Units, ensuring implementation and continuous development of Quality systems and programs, performance monitoring.
- Evaluate Quality performance (KPIs and Quality reporting), report progresses and issues to QA management and ensure appropriate and timely follow up on action plans and programs successfully through preparation, execution and follow-up of health authority inspections and to determine trends and opportunities for continuous quality improvement
- Support in TpT and OTBA initiatives (NOSCEE SPOC), ensuring alignment with global standards
- Provide guidance to ensure continuous organizational improvement and development to drive Operational Excellence & better financial outcomes
- Drive harmonisation and process improvements initiatives across sites
- Act as Supply QA contact and support Annex 16 clarifications
- Responsible to ensure Artwork problems are adequately managed and follow up measures are implemented
- Coordinate and support Supplier certification program
- Perform compliance checks in site and support escalation process
- Support quality escalation processes, ensuring timely communication and robust resolution of critical quality events
Obligatory requirements:
- Education: Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science.
- 15 years of experience in manufacturing of biopharmaceuticals drug products and Quality Assurance.
- Operational knowledge of aseptic processing and medical device quality requirements.
- Excellent GMP knowledge and aseptic environments.
- QA / QC knowledge and solid experience with Authorities´ inspections.
- Fluent English, written and spoken.
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
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
