Documentation and Training Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description SCOPE AND RESPONSIBILITIES: The Documentation and Training Specialist contributes to the proper maintenance of GMP documentation at the site by issuing, controlled management, and withdrawal of reference documentation and related personnel training. Additionally, the Documentation & Training Specialist will conduct training sessions on GMP topics, applications, and digital/Software supports to ensure high-quality on-site training and support. SPECIFIC TASKS/PRIMARY ACTIVITIES: Assist in managing the alignment of SOPs and Corporate Curriculum at the site, facilitating the drafting of gap assessments by impacted departments and updating training plans with the assignment of training based on Global Curriculums. Responsible for managing the documentation of the Quality System department (Documentation and Training) in terms of archiving, cessation, and disposal according to current procedures. Collaborate in managing the corporate training system (SFLMS), managing personnel training related to controlled document issuance where applicable. Ensure the proper updating of curricula, training pathways, and subsequent system integration in SFLMS for all site employees to maintain alignment between requirements and training. Work with all departments to identify digital and non-digital learning needs and include new training courses in the GMP training platform. Design, plan, and deliver training courses, including digital ones where necessary. Train personnel on GMP, supporting onboarding processes for new hires, external consultants, and suppliers. Collaborate in managing the corporate training system respecting Data Integrity and Compliance (SAP SuccessFactors - SFLMS). Help define and implement the personnel training plan for sterile area operations. Assist in drafting, updating, and applying the Training Master Plan. Monitor qualification, training, and support material deadlines (CO, TP). Create and manage digital training courses using advanced devices (Hololens, Matterport Scan, Camtasia, Guides, e-learning tools, etc.). Support initiatives related to Operational Excellence and identified improvement projects for the department and/or site. Provide support during audits, client inspections, and regulatory reviews concerning the Quality System department. Requirements: Degree in scientific fields (Chemistry, Pharmacy, Biology, etc.). Previous experience in QA functions within pharmaceutical companies and knowledge of GMP guidelines. Proficiency in Microsoft Office (especially Excel). Basic knowledge of English. Basic knowledge of the training management system (SAP platform) SFLMS. J-18808-Ljbffr

Location: monza, IT

Posted Date: 6/27/2025