Job Description

Regulated Document Management Specialist

Location :- Coimbatore
Experience :- 2+ Years

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. Join us in helping leading Life Sciences and regulated-industry organizations strengthen compliance, quality, and document governance through innovative and efficient documentation processes.

Your Role

As a Regulated Document Management Specialist, you will be responsible for managing regulated quality documentation throughout its lifecycle within a Life Sciences, Pharmaceutical, Medical Device, Healthcare, or Tobacco environment. You will work closely with Quality, Regulatory, Manufacturing, R&D, and Compliance teams to ensure documentation accuracy, traceability, and audit readiness while supporting continuous improvement initiatives.

In this role, you will:

• 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, and controlled distribution.
• 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.
• Coordinate document review and approval activities with stakeholders across Quality, Regulatory, Manufacturing, Training, and R&D functions.
• Support regulatory inspections, audits, and compliance activities by maintaining readily retrievable and approved documentation.
• Monitor document status, aging reports, review cycles, overdue actions, and workflow metrics.
• Support document migration, repository cleanup, and data reconciliation activities during system transitions.

Your Profile

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Medical Sciences, Engineering, Quality Management, or a related discipline.
• Minimum 2+ years of experience in Document Management, Quality Assurance, Compliance, Regulatory Operations, or Quality Systems within a regulated industry.
• Strong understanding of Life Sciences, Pharmaceutical, Biotechnology, Medical Device, Healthcare, or Tobacco industry requirements.
• Hands-on experience in Compliance, Regulatory Operations, Quality Assurance, Quality Systems, or regulated quality operations.
• Knowledge of QMS principles, controlled documentation, audit readiness, data integrity, and document control processes.
• Experience managing controlled document lifecycles and document/records control activities.
• Exposure to eDMS or controlled repositories such as Veeva Vault, OpenText/Documentum, MasterControl, TrackWise, SharePoint, or equivalent platforms.
• Experience supporting audits, inspections, CAPA, change control, or quality compliance activities is preferred.

About Us

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and consultants to help the world's most innovative companies unleash their potential. From life sciences and healthcare innovations to next-generation industry solutions, our experts provide unique R&D and engineering services across industries. Join us for a career full of opportunities where you can make a difference every day.