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Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine diagnostics and therapeutics. 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.
The Quality Control Analyst will be responsible for Quality Control Chemical and Microbiological testing of Product and Raw Materials/packaging components as well operation/maintenance of analytical instrumentation in accordance with cGMP/FDA regulations, AAA standard operating procedures and Policies. Due to the nature of the process (radioactive) this role requires moderate proficiency, of the basic quality control techniques, analytical instrumentation, sterility principles and understanding of radiation safety standards.
General responsibilities will include but are not limited to the following: * Supports all technical aspects related to quality control testing readiness including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, in full compliance with GMP regulation, AAA procedures and Product specifications * Responsible for the oversight on Manufacturing for QC sampling activities * Product testing and Environmental Monitoring QC testing and reporting of the results. Escalate in case of non-conformances and deviations, and manage these quality incidents as per AAA procedures * Assist on deviation investigations, OOS/OOT investigations, CAPAs follow up and implementation and Change Controls * Participation in assigned qualification/validation activities, as necessary; Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications and other relevant training including HSE for the specific role * Prepares applicable documents, forms and records such as analytical batch records and follows Good Documentation Practices and Support Audits and Inspections as required