Sanofi: Junior Quality Specialist Bardi

Sanofi: Junior Quality Specialist
Bardi
Emilia Romagna, Bardi

Purpose of roleIn context of Country Quality organization based on Milan headquarter, we are looking for a Junior Quality Specialist who support and assure a quality oversight on quality processes/ activities to all GXP process at country level. Person profile and required skills and qualificationsEducation (specialization):

Bachelor of Pharmacy Degree or any science/ medical related degree. Master degree in Quality Systems, ISO 9001 is preferential. Work Experience:

English language (advanced in written and spoken). GMP/GDP regulation. EU MDR Regulation (Medical Devices). Management of Quality Systems (SOPs, records, deviations, CAPA, change control, audit/inspection, annual review, computerized systems). Quality Risk Management. Data Integrity principles. Skills and Competencies:

support in preparation of annual quality training plan involving colleagues of other of GxP functions. Support implementation of the annual Country Quality Review. Deviation and Corrective-Preventive Actions (CAPA) management:

support and implement proper management of deviations and CAPAs including those related to audits and inspection findings, according local SOP. Country Quality key performance indicators (KPIs):

ensure timely collecting and reporting in SQUARE of country KPIs. Country Quality agreements:

ensure that valid and signed quality agreements for all GXP/GDP/GMP activities under the responsibility of Quality within the country organization. Quality oversight of locally managed GxP subcontractors:

support in preparation of an annual audit plan for locally managed subcontractors for all GxP and health-regulated activities. Quality risk management:

Support CQH in managing Quality Risk Management matters according local and global SOPs. Product complaints overview of the process. Conduct product complaints trend analysis and signal detection, as appropriate. Product-related quality events:

Support CQH in managing quality alerts and product recalls documentation and reports as per global process and local SOP. Ensure quality oversight on management of product distribution issues including:

temperature excursion, returns, shipment under quarantine and consequent release to the market. Support CQH in preparing communication to national Health Authorities. Support Repackaging operations and quarantine shipments are performed locally. Product Quality Review. We are proud to have been awarded Global Top Employer 2021. #LI-EUR