Join Capgemini Engineering, a global leader in engineering services, as a Regulated Document Management Specialist. This role is ideal for professionals experienced in Life Sciences or Tobacco industries seeking to enhance compliance, quality, and document governance within regulated environments. You will be instrumental in managing critical quality documentation throughout its entire lifecycle, collaborating with cross-functional teams to ensure accuracy and audit readiness.

At Capgemini, we empower our team members to shape their careers within a supportive global community. We encourage innovation and provide opportunities to make a tangible difference in areas ranging from life sciences to advanced robotics. Discover a career where each day presents new challenges and possibilities.

Manage the complete lifecycle of controlled documents, including SOPs, work instructions, and quality records, from creation to retirement. Administer document workflows, maintain metadata, ensure version control, manage effective dates, and oversee retention, archival, and distribution processes.

Conduct thorough quality reviews to guarantee document completeness, consistency, and adherence to regulatory standards. Support the Quality Management System (QMS) by maintaining repository accuracy and facilitating document review and approval activities across various departments like Quality, Regulatory, Manufacturing, Training, and R&D.

Assist with regulatory inspections and audits by ensuring documentation is readily accessible and approved. Monitor document status, review cycles, and workflow metrics to identify areas for improvement. Contribute to document migration and repository cleanup efforts during system transitions.

A Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, Biotechnology, or Engineering is required. A minimum of 2 years' experience in Document Management, Quality Assurance, Compliance, or Quality Systems within a regulated industry is essential.

Demonstrate a strong understanding of Life Sciences, Pharmaceutical, Medical Device, Healthcare, or Tobacco industry regulations. Familiarity with QMS principles, controlled documentation, audit readiness, and data integrity is crucial. Experience with electronic document management systems (eDMS) or controlled repositories is a plus.

Previous experience in supporting audits, inspections, CAPA, or change control processes is highly preferred. This role offers a permanent contract within our Products & Systems Engineering community.