QA Training & Documentation Specialist
OverviewYou will support Global Technical Operations & Supply by governing training and documentation systems. You’ll implement the new electronic document management project and ensure compliance with regulatory standards. The role sits at the crossroads of quality, training, and regulatory affairs, enabling consistent, documented processes across sites. You will partner with cross‑functional teams to drive governance and continuous improvement in documentation and training. This opportunity lets you shape how we manage critical knowledge and stay compliant at scale.
Retribuzione / Benefits
pensionprivate medical insurancewellbeing programmeflexible benefits programmerelocation supportremote work options
Responsabilità
Describe and issue procedures for the document management system and its requirementsArchive and manage the Central Archive of documentationMaintain the Electronic Documentation Management System (EDMS)
aligned with regulatory requirementsProvide user training for the EDMSSupport users in the document management system usageMonitor document expiration and ensure timely confirmation or revisionQuality check and verify documentsDistribute documents to suppliersEnsure compliance of training and documentation with regulationsParticipate in governance for the training management systemEvaluate and authorize access to computerized systems in the GMD areaSupport audits by regulatory authorities or clientsSupport Corporate Quality auditsEnter training event data into the training management system and report itConfigure job roles and training plansArchive general training documentationSupport LMS usersOrganize training courses per Training ProgramExtract and process training data from the LMSSupport training improvement projects in GMD
Requisiti fondamentali
Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)At least 5 years in pharmaceutical/biopharmaceutical manufacturing with a strong QA track recordExcellent knowledge of EU and FDA pharmaceutical guidelinesProven ability to manage multiple projectsSpecialized expertise in GMP compliance improvement processesStrong teamwork and constructive collaborationAnalytical problem-solving with risk assessmentFluent English (written and spoken)teamworkproblem-solvingcommunicationElectronic Documentation Management System (EDMS)Training Management SystemLearning Management System (LMS)
Retribuzione / Benefits
pensionprivate medical insurancewellbeing programmeflexible benefits programmerelocation supportremote work options
Responsabilità
Describe and issue procedures for the document management system and its requirementsArchive and manage the Central Archive of documentationMaintain the Electronic Documentation Management System (EDMS)
aligned with regulatory requirementsProvide user training for the EDMSSupport users in the document management system usageMonitor document expiration and ensure timely confirmation or revisionQuality check and verify documentsDistribute documents to suppliersEnsure compliance of training and documentation with regulationsParticipate in governance for the training management systemEvaluate and authorize access to computerized systems in the GMD areaSupport audits by regulatory authorities or clientsSupport Corporate Quality auditsEnter training event data into the training management system and report itConfigure job roles and training plansArchive general training documentationSupport LMS usersOrganize training courses per Training ProgramExtract and process training data from the LMSSupport training improvement projects in GMD
Requisiti fondamentali
Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)At least 5 years in pharmaceutical/biopharmaceutical manufacturing with a strong QA track recordExcellent knowledge of EU and FDA pharmaceutical guidelinesProven ability to manage multiple projectsSpecialized expertise in GMP compliance improvement processesStrong teamwork and constructive collaborationAnalytical problem-solving with risk assessmentFluent English (written and spoken)teamworkproblem-solvingcommunicationElectronic Documentation Management System (EDMS)Training Management SystemLearning Management System (LMS)