Documentation and Training Specialist

Thermo Fisher Scientific Inc.; Ferentino; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is looking for a Documentation and Training Specialist. The successful candidate will be responsible for managing GMP documentation and ensuring proper training delivery using innovative digital tools. Candidates should have a relevant degree and experience in Quality Assurance within a GMP environment.

Competenze

• Previous experience in QA functions within pharmaceutical companies.
• Basic knowledge of English.
• Familiarity with training management systems is beneficial.

Mansioni

• Manage GMP documentation and conduct related trainings.
• Collaborate with other departments to assess training needs.
• Develop and implement training plans for personnel.

Conoscenze

GMP knowledge

Proficiency in Excel

Digital training course development

Training management

Formazione

Degree in scientific fields (Chemistry, Pharmacy, Biology)

Strumenti

SAP SuccessFactors (SFLMS)

Office Suite

Descrizione del lavoro

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

SCOPE OF THE POSITION/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 I will conduct training sessions for users on GMP topics, applications, and digital/software supports to ensure a high level of on-site training and support.

SPECIFIC PRIMARY TASKS/ACTIVITIES:

• Collaborates in managing the alignment of SOPs and Corporate Curriculum at the site, facilitating the drafting of gap assessments for impacted departments and updating training plans with the related assignment of training based on Global Curricula.

• Responsible for managing the documentation of the Quality System department (Documentation and Training) in terms of archiving, cessation, and deletion according to current procedures.

• Assists in managing the corporate training system (SFLMS), managing personnel training related to controlled document issuance where applicable.

• Ensures the correct updating of curricula, training paths, and their subsequent association with the SFLMS system for all site employees to ensure proper alignment between requirements and training.

• Collaborates with all departments to identify digital and non-digital learning needs and includes new training courses in the GMP training platform of the site.

• Designs, plans, and delivers training courses, including digital ones where necessary.

• Conducts GMP training for personnel supporting onboarding processes for new resources, external consultants, and suppliers.

• Collaborates in managing the corporate training system respecting Data Integrity and Compliance (SAP SuccessFactors - SFLMS).

• Works on defining and implementing the training plan for personnel operating in sterile areas.

• Supports the drafting, updating, and application of the Training Master Plan.

• Responsible for monitoring qualification, training, and support material deadlines (CO, TP).

• Develops, creates, and manages digital training courses using advanced devices (Hololens, Matterport Scan, Camtasia, Guides, e-learning tools, etc.).

• Supports initiatives in Operational Excellence and projects identified as improvements for the department and/or site.

• Provides support during audits, client inspections, and regulatory reviews regarding the Quality System department.

Requirements:

• Degree in scientific fields (Chemistry, Pharmacy, Biology).
• Previous experience in QA functions within pharmaceutical companies and knowledge of GMP guidelines.

• Proficiency in Office Suite (especially Excel).

• Basic knowledge of English.

• Basic knowledge of the training management system (SAP platform) SFLMS.