QA Manager ESO Chemicals and AI (m/f/d)
- Ljubljana, Slovenia
As QA Manager ESO Chemicals and AI (m/f) you will support approving and maintaining quality oversight with respect to supply of materials to Novartis, from external suppliers of chemicals by working in Supply Relationship Teams. Support ensuring appropriate quality oversight, assessment and mitigation of quality risks, that may potentially negatively impact the supply of purchased strategic ESO chemicals (regulatory starting materials, Intermediates and API's).
Your key responsibilities
• Responsible to support quality oversight for purchased API's and strategically important regulatory starting materials and chemical intermediates supplied into Novartis NTO sites worldwide.
• Participates and supports changes of supplier qualification and certification status for all external Suppliers.
• Manages major and critical quality issues (reclamations, stability issues etc.) and ensures investigations are correctly executed.
• Performs risk assessments in case of specific quality events at supplier, including collecting relevant data from NTO sites and other stakeholders, and approval of site specific risk assessments where required. Evaluate risks for product quality and patient safety and proposes market actions.
• Participates in High Risk Supplier evaluation process, and assures that actions originating from this process are executed and properly documented. Proactively communicates supplier status changes (incl. high risk suppliers) with NTO sites.
• Provide direction and support to third parties and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties to ensure that the materials produced meet the Novartis quality, efficacy and safety requirements.
• Responsible for preparing Quality Agreements and Quality Risk assessments for specific External Suppliers.
What you will bring to the role
• Bachelor or higher in Biochemistry, Chemistry or another related science.
• At least 1 year of experience (preferred more) in Pharmaceutical industry, Quality control and/or other relevant operational areas.
• Fluent in English.
• Good communication skills, proactivity, self initiative.
• Ability to operate in a global matrix environment
We offer permanent employment, with 6 months of probation period.
You are kindly encouraged to submit your application in English language, including CV by 25th of October 2020.
Why consider Novartis?
750 million. That's how many lives our products touch. 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.
We are Novartis. Join us and help us reimagine medicine.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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