.Summary: The Quality Assurance Specialist supports the maintenance at local level of the national quality management system as per GMP regulation and corporate guidelines as well as of all health regulated activities.
About the Role: For this role we offer a temporary contract.
Major Accountabilities: Participate in self-inspections as per the approved annual plan and external audits (Health Authorities, Certified Bodies, Supplier) or internal audits (QA global department of the company).
Manage at local level the follow-up of the CAPAs implementation.
Assure the respect of the GMPs and Health Authorities requirements at local level and the compliance of the local quality system to the GMPs and corporate guidelines.
Safeguard the quality of the medicinal products which have been manufactured by the radiopharmaceutical site.
Support the APR achievement according to the calendar and assure the correct registration and archiving of the documentation at local level.
Assure the execution of qualification, maintenance, calibration, and revalidation programs at local level.
Ensure the accomplishment of the ALCOA+ principles; ensure that Out of specifications, Out of trends, deviations, CAPA, and Change controls are addressed and recorded according to c GMP and SOPs.
Participate, at local level, in the execution of the staff GMP training and the respect of the training annual plan.
Assure the escalation to the Quality Site Head and to the Quality National Head in case of critical issues.
Obligatory Requirements: Education: Scientific Degree (Pharmacy, Chemistry, Biology or similar).
2+ years of experience in a Quality Assurance department.
Strong affinity with and awareness of quality issues.
Good organizational skills including attention to details.
Solid knowledge of quality systems (GMP).
Basic knowledge of regulatory requirements is preferred.
Fluent in English and Spanish (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.
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.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve