Location
Barcelona | Spain
Job description
About the Role
Location: Barcelona, Spain.
About the role:
As Complaint Hub Associate you will ensure and support overall GxP conformity and compliance with the Novartis Quality management systems, the law and other policies / procedures in processes like e.g. document management, change control system, training, escalation management, risk management, qualification / validation and CSV. You will also manage quality aspects and projects within area of responsibility.
We offer a fixed-term contract of six months.
Key responsibilities:
- 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 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.
- Lead and participation on GxP projects and processes. Continuous improvement & process efficiency. Ambassador of this Culture.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential requirements:
- Degree in Sciences/Pharmacy
- 3 years of experience in Quality Assurance department.
- Strong Knowledge on GMP & other regulations as: GCP, GDP, ICH, ISO.
- English fluent Written and Spoken.
- Intermediate level of German language is required
You’ll receive:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
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?
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:
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