Quality Assurance Specialist
Location
Zaragoza | Spain
Job description
About the Role
Work location:La Almunia de Doña Godina (Zaragoza).
We are a Novartis Company focused on transforming patients’ lives by leading innovation in nuclear medicine.
As QA Specialist you'll support all the activities GMP related (operational and strategic), in order to guarantee the compliance with the regulatory requirements, quality standards and SOP in use.
Your responsibilities include, but are not limited to:
• Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site.
• Ensure that the company manufacturing objectives and policies are consistent with GMPs.
• Support the development and implementation of projects related to new or existing products.
• Ensure the correct storage of Reference and Retention Samples of the raw materials and products.
• Guarantee the correct labeling of storage containers for raw materials.
• Approve/verify the documentation (batch record, specifications, sampling and control methods, QC procedures, protocols).
• Guarantee the correct document lifecycle management (paper and electronic system).
• Update the lists of documents related to the Quality Management System based on the indications of the reference SOPs.
• Collaborate in drafting of Site Master File and Validation Master Plan.
• Manage product complaints, CAPAs and change controls.
• Handle the deviations as Certified Lead Investigator or QA Approver.
• Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.
• Support the preparation and execution of internal audits and Health Authorities inspections.
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
Obligatory requirements:
• Education: Degree in Pharmacy
• 1+ years of experience in a Quality department in a Pharma/Manufacturing sector or analytical lab in a GMP environment
• Strong affinity with and awareness of quality issues
• Good organizational skills including attention to details
• Solid knowledge of quality system (GMP)
• Basic knowledge of regulatory requirements
• Spanish and English fluent, written and spoken
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
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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?
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