Training and Documentation Specialist

Job title:Training and Documentation Specialist

• Location: Singapore

About the Job:

Sanofi's Manufacturing & Supply organization is building the future of vaccine and Specialty Care Biologics production through the Modulus Facility programme, a new generation of modular, agile, multi-product facilities. The Tuas (Singapore) greenfield site mirrors the one in Neuville (France) and will be highly digitalized, using technologies such as AGVs, cobots and cloud systems. In this role, you will develop and deliver GMP training, administer the iLearn learning management system (learning objects, assignments, catalogue, reports and learner support), and manage the GxP documentation lifecycle. You will keep the documentation lean, accurate and compliant, support audits and inspections, and contribute to QMS processes such as Deviation, CAPA and Change Control. The ideal candidate holds a Bachelor's degree in Pharmacy, Science, Engineering or a related field, has at least 4 years of pharma or biotech experience, and brings strong analytical, communication and collaboration skills, along with familiarity with Digital 4.0 concepts in Quality.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Main Accountabilities:

For Training

• Contributing to develop and implement annual training programs to ensure compliance with Good Manufacturing Practices (GMP) and company standards
• Contributing to identify training needs and developing customized training plans
• Supporting the managers in the establishment of the curricula for the different areas
• Developing training materials with the support of the relevant subject matter expert to address the training needs and plans
• Conducting training sessions for new hires and existing employees on specific topics
• Evaluating training effectiveness through assessments, feedback, and performance metrics
• Support relevant subject matter expert in updating training materials to reflect changes in regulations, procedures, and best practices
• Leading continuous improvement initiatives to enhance training material and processes
• Providing support during regulatory inspections and audits by presenting training records, training process and material
• Contribute to QMS processes related training activities (e.g., Deviation, CAPA, Change Control) for the site
• Perform iLearn administration activities (e.g., management of Learning Objects, Groups, Assignment, execute dedicated reports), to support the Quality and HSE training needs for his/her perimeter according to his/her permissions
• Identify best approach to operate the learning offer in iLearn by applying approved Ways of Working
• Support manager and training specialist to elaborate training plan in compliance with iLearn best practices Stay abreast of the tool functionalities evolution by following the corresponding training within defined timelines
• Ensure alignment with other decentralized administrators by participating in regular coordination meetings
• Ensure the updating and management of the training catalog available in iLearn
• Contribute to site projects requiring LMS expertise
• In the framework of the permissions granted, execute the administrative activities in iLearn in compliance with all applicable work instructions such as:
  • Creation, modification, and re-versioning and inactivation of specific learning objects such as Online Courses, On the Job Training, creation of event/session for face-to-face or virtual training, according to the approved processes (i.e., incl. Test in P2)
  • Request the creation of non-Workday user profiles in accordance with iLearn User profile requirements, with global interface for requests.
  • Management of groups
  • Learning assignments, registration and completion management.
  • Run reports
• Liaise with global iLearn Operations team to perform activities not included in the decentralized administrator permissions.
• Ensure full compliance of all activities with iLearn Operations Global Quality documents applicable to the role and respond diligently to iLearn Quality Control requests for data updates and corrections
• May contribute to deviation investigation or analysis (linked to the tool or the interface with other tools)
• Support audits and inspections as needed e.g. to demonstrate the tool operation, providing inspection reports.
• Ensure level 2 support to learners
• Contribute to iLearn Learner support improvement (knowledge base enrichment
• Contribute in iLearn administration evolution projects (process improvement, testing…).
• May contribute to the Decentralized activities for other sites or entities as back up or support. Three levels of permissions related to the scope / perimeter can be granted to administrators based on their level of proficiency and according to M&S needs:
  • Local Administrator: Access limited to a specific entity, site or country.
  • Regional Administrator: Access across multiple sites within a defined region.
  • Global Administrator: Access to data across all perimeters (M&S).
• Commitment to Compliance with the General Data Protection Regulation (GDPR) As part of our commitment to safeguarding personal data and maintaining trust with our employees, this role includes key responsibilities and knowledge of General Data Protection Regulation (GDPR) compliance and data protection principles.

For Documentation

• Managing the GxP documentation lifecycle (creation, revision, and obsolescence)
• Collaborating with other departments to ensure document content addresses the business needs and processes
• Ensuring, with the support of relevant experts that the documentation content is compliant with regulatory requirements and company standards
• Ensuring the overall documentation package is kept lean (i.e., avoiding redundancies and duplication)
• Ensuring accuracy, completeness, and compliance of the documentation with writing rules (incl. clarity and grammar)
• Collecting needs for documentation changes, prioritizing and managing document update
• Ensuring the documentation is regularly updated to remain current and aligned with the needs and processes
• Ensuring document distribution and access complies with the information classification level
• Supporting internal and external audits and inspection by ensuring all required documents are up-to-date and retrievable
• Representing the site in the documentation CoP led by global and, if requested, participating in the CoE and ensuring local communication

About You

Education:

• Bachelor’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields. 

Expected Experience: 

• A minimum of 4 years of relevant experience in the pharmaceutical or biotechnology industry.

Expected Technical and Soft Skills:

• Ability to analyze complex data sets and identify patterns, discrepancies, and areas for improvement
• Strong verbal and written communication skills to effectively train staff, report findings, and collaborate with various departments
• Very good communication skills to be able to face audit and inspections
• Proven ability to work as part of an integrated, networked team, and collaborate across functional, organizational, and location boundaries and be people-first values driven
• Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based quality decisions
• Engaging, dynamicAdaptable, relationship focusedSelf-organized, able to work independently with little supervision.
• Proactive, Result-orientedDriven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
• Good communication skills to present strategies to the site management and other functions.
• Familiar with Digital 4.0 concepts and potential applications in Quality.

Why Choose Us?

Sanofi offers the chance to shape how life-saving medicines and vaccines are made. Here is what this role brings:

• Impact at scale: Your work supports the delivery of 4.3 billion healthcare solutions every year, protecting people from infectious diseases and bringing hope to patients and families.
• Pioneering manufacturing: You will join the Modulus programme, building a new generation of modular, digitalized facilities from the ground up at the Tuas greenfield site.
• Cutting-edge technology: You will work with automation and digital tools such as AGVs, cobots and cloud systems, and develop your Digital 4.0 expertise in Quality.
• Broad, hands-on scope: The role combines GMP training, LMS administration and GxP documentation, giving you exposure to training design, quality systems, audits and inspections.
• Career growth: You can progress from site-level administration to Regional or Global administrator permissions, and represent the site in global Communities of Practice.
• Collaborative culture: You will work across functions and locations with global partners, in a people-first, values-driven environment.

PursueProgress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.