DirecciónWork 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.
Hace 4 horas
