Zusammenfassung
About the Role
We offer a temporary contract of 6 months, with possibility of extension.
Major accountabilities:
- Responsible for handling of technical market complaints and processing in e-QMS, by completing an initial assessment and closure of the complaints.
- Initiating escalation, when required, and following up with responsible country quality for supplementary data.
- SPoC for stakeholders, e.g. investigation sites, ESO QA, NPS, Med Info-Call Centers, etc...
- SPoC for local cases in Spain supporting and/or participating in NEM cases as required. Member of Local Committee - Quality Assessments.
- Responsible for performing local reconciliation activities with stakeholders as Patient safety/Medical Info with all countries in scope.
- Prepare draft feedback letters and sharing it with stakeholders.
- Responsible for complaint sample management related with Spanish customers (cases).
- Responsible for preparing Quality trends (Spanish cases) and driving continuous improvement for processes and product quality performance.
- Ensure that local Quality System and SOPs are in place for all GxP related activities under complaint landscape and that compliancce with cSMP is maintained through training and internal audits.
Minimum Requirements:
Work Experience:
- Degree in a Scientific or Technology field (e.g. Chemistry, Pharmacy or other Life Science).
- Minimum 3 years of experience in Quality or in Quality Assurance department.
- Solid Knowledge on GMP & other regulations as: GCP, GDP, ICH, ISO
- Fluent Spanish and English, written and spoken. French and German knowledge will be highly valued.
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
You will receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
