Join Capgemini Engineering, a global leader in engineering services, and contribute to innovative documentation processes within the Life Sciences and regulated industries. Empowering you to shape your career, this role supports leading organizations in strengthening compliance, quality, and document governance.

As a Regulated Document Management Specialist, you will oversee the entire lifecycle of regulated quality documentation. You will collaborate with various departments to ensure accuracy, traceability, and audit readiness, driving continuous improvement initiatives in a dynamic environment.

Manage a range of controlled documents, from SOPs to quality records, throughout their lifecycle, including creation, review, and retirement. Administer critical document lifecycle activities such as workflow management, metadata updates, version control, and retention policies. Conduct thorough quality reviews to verify document completeness, consistency, traceability, and adherence to regulatory standards and templates. Support the Quality Management System (QMS) by maintaining repository accuracy and coordinating document review processes across multiple teams. Prepare for and support regulatory inspections and audits by ensuring documentation is readily accessible and approved.

A Bachelor's degree in a relevant Life Science, Pharmacy, Biotechnology, Medical Science, Engineering, or Quality Management discipline is required. Possess a minimum of 2 years of experience in document management, quality assurance, compliance, or related roles within regulated industries. Demonstrate a strong understanding of Life Sciences, Pharmaceutical, Medical Device, Healthcare, or Tobacco industry requirements and QMS principles. Familiarity with eDMS or controlled repositories like Veeva Vault, OpenText/Documentum, MasterControl, TrackWise, or SharePoint is advantageous. Experience supporting audits, CAPA, or change control activities is a plus.