Training and Documentation Specialist

About the role

Sanofi's Manufacturing & Supply organization is building the Modulus Facility programme, a new generation of modular, agile, multi-product vaccine and specialty care biologics facilities. The Tuas (Singapore) greenfield site is 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 and manage the GxP documentation lifecycle, keeping documentation lean, accurate and compliant while supporting audits and inspections.

Key responsibilities

• Help develop and implement annual GMP-compliant training programmes, identify training needs and create customized training plans
• Develop training materials with subject matter experts, run training sessions and evaluate effectiveness through assessments and feedback
• Support regulators' inspections and audits by presenting training records and materials, and contribute to QMS processes such as Deviation, CAPA and Change Control
• Administer iLearn: manage learning objects, groups and assignments, run reports, maintain the training catalog and support learners
• Manage the GxP documentation lifecycle (creation, revision, obsolescence), keep it lean and compliant, and ensure accurate distribution and access
• Support internal and external audits and inspections, and represent the site in documentation Communities of Practice
• Comply with GDPR and follow the General Data Protection Regulation

Required profile

• Bachelor's degree in Pharmacy, Science, Engineering or a related field
• At least 4 years of experience in the pharmaceutical or biotechnology industry
• Familiarity with Digital 4.0 concepts in Quality

Required skills

• Analytical, communication and collaboration skills
• Ability to analyze complex data sets and make data-based quality decisions
• Strong verbal and written communication, including presenting to site management and facing audits
• Ability to work independently and in cross-functional teams