Job ID294306BRPosition TitlePharmaceutical & QA SpecialistApply to JobAAA Statement 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).
Job Description
The Pharmaceutical & QA Specialist will support the Technical Manager in a selection of tasks related to daily procedures. Please note this is a part-time role (80%).
• Guarantee the release of the batches produced in Europe or USA and distributed in Switzerland (may act as the back-up person for this activity)
• Participate in managing the master batch records of the radiopharmaceutical products
• Act as the back-up person in the absence of the Technical Manager
• Participate in managing the DTA, OOS, CAPA and Change Control
• Organize the Quality Assurance system in accordance with the GMP and GDP rules
• Maintain and harmonize a Quality Assurance system
• Maintain controlled edition and distribution of documents, as well as manage their implementation and life cycle
• Participate in the edition of new quality documents as per required
• Help at encoding and treating customer and third-party complaints, as well as assist the Technical Manager in replying to the customer in due course (may act as the back-up person for this activity)
• Participate in the internal audit inspections and support the Technical Manager
• Support the Technical Manager in the preparation of the Health authority’s inspections
• Manage the pharmacovigilance measures relating to all the products injected
• Ensure compliance with AAA procedures and applicable Swiss regulations
Minimum requirements
• University degree in Pharmacy, Chemistry, Life-Science or related field
• Excellent verbal and written communication skills in French and English (German and Italian would be a plus)
• Understanding and acknowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
• Experience in Quality Assurance field
• Experience in Management of Documentation is a must
• Past-experience in the Pharmacovigilance field would be a plus
• Practical knowledge of office tools and cognate software is essential
• Reliable, flexible, available, ability to build strong relationships, highly self-organizedDivisionOncologyBusiness UnitADVANCED ACCELERATOR APPLICATIONSLocationSwitzerlandSiteGenevaCompany/Legal EntityAAA International SAFunctional AreaQualityJob TypePart Time (80%)Employment TypeRegularShift WorkNo
