QA Specialist
Novartis
Software Engineering, Quality Assurance
Spain
Posted on Friday, May 26, 2023
11! That’s the average number of batches will be released a week at Advanced Accelerator Applications Molecular Imaging, Zaragoza. We are a Novartis Company focused on transforming patients’ lives by leading innovation in nuclear medicine. We are 1 of 4 platforms of the Novartis Oncology Bold4Cure Strategy.
As part of your continued professional development, you will receive full training in this specialist 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.
This role is based in La Almunia de Doña Godina, Zaragoza
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.
• Draft Annual Product Quality Review.
• Collaborate in drafting of Site Master File and Validation Master Plan.
• Manage the product complaints.
• Manage 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.
• Assure the execution and the proper documentation of training activities in the site.
As part of your continued professional development, you will receive full training in this specialist 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.
This role is based in La Almunia de Doña Godina, Zaragoza
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.
• Draft Annual Product Quality Review.
• Collaborate in drafting of Site Master File and Validation Master Plan.
• Manage the product complaints.
• Manage 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.
• Assure the execution and the proper documentation of training activities in the site.
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