Novartis Pharmaceuticals Quality Assurance / Qualified Person in Zaragoza, Spain
The QP/QA Manager is in charge of 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 ensuring that all the relevant external and internal requirements are implemented, monitored for performance and adherence.
Ensures that each batch of medicinal product is produced and controlled in observance of the legal regulations and the conditions set at the time the drug marketing authorisation is granted.
Release the batches of radiopharmaceuticals produced at the pharmaceutical plant inaccording to Directive 2001/83/EC for Medicinal products for human use and National laws.
Collaborate with the Quality Assurance department in maintaining the validation/qualification status of the production site, equipment, training of
personnel and management of quality documentation;
Participate in the compliance of the local quality system to the GMPs and corporate guidelines
Assure the respect of the GMPs and Health Authorities requirements at local level
Safeguarding of the quality of the medicinal products which have been manufactured by the radiopharmaceutical site
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;
Act directly to the annual quality audit
Ensure that Out of specifications, Out of trends, deviations, CAPA, Change controls are addressed and recorded according to cGMP and SOPs
Participate to the self-inspections as per approved annual plan and to the external audits (Health Authorities, Certified Bodies, Supplier)
Complaint management at local level
Assure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities requirements
Quality Assurance / Qualified Person
Scientific Degree (Preferred Pharmacist - qualification to Qualified Person)
English: fluent spoken and writing
+2 years of experience in a Quality department
Strong affinity with and awareness of quality issues
Good organizational skills including attention to details
Knowledge of quality system (GMP)
Basic knowledge of regulatory requirements
Shows the appropriate sense of urgency around given tasks, work in team
AAA Ibérica S.L.U.
ADVANCED ACCELERATOR APPLICATIONS
Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).