MAIN ACCOUNTABILITIES AND DUTIES
Operational skillsOperational quality management of a dedicated product portfolio which includes:
Quality management of deviation and complaint records and their related CAPAsAssessment and management of change controlsEdition of QA Agreements with Zentiva third parties and subcontractorsCollection and evaluation of PQRs and stability dataCompliance evaluation of Third Parties and productsMaintenance of product databaseCollection and review of CoA/CoCQA support of product launches and transfersGMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislationsAuditingPrepare audit and audit plansConduct and participate to external auditsEvaluation of audit reportsParticipate to internal audits and inspectionsKPI monitoring and reportingOther tasks may be performed under the d...