Quality Assurance Specialist

For this role we offer a temporary contract. Major Accountabilities Participate in the self-inspections as per approved annual plan and to the 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 cGMP 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 detail. Solid knowledge of quality system (GMP). Basic knowledge of regulatory requirements is preferred. Fluent in English and Spanish (written and spoken). #J-18808-Ljbffr