Regulated Document Management Specialist (Life Sciences/Tobacco
CoimbatoreFull-time2–5 yrsPosted 2 weeks ago
Mid-level pharma role at Capgemini in Coimbatore. Needs 2+ years and a B.Sc.
About the role
Choosing Capgemini means choosing a place where you'll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what's possible.
What you'll do
- Work closely with Quality, Regulatory, Manufacturing, R&D, and Compliance teams to ensure documentation accuracy, traceability
- Manage controlled documents including SOPs, work instructions, job aids, forms, specifications, and quality records from creation through retirement
- Administer document lifecycle activities including workflow management, metadata maintenance, version control, effective-date management, retention, archival
- Perform quality reviews to ensure document completeness, consistency, traceability, approved templates, and compliance with regulatory requirements
- Support Quality Management System (QMS) documentation processes and maintain repository accuracy
What you need
- Microbiology
- Documentation
- ISO 9001
- SOP writing
- Reconciliation