Regulated Document Management Specialist (Life SciencesTobacco

Capgemini · IT Services & Consulting

Coimbatore, India
On-site
Posted today
Apply by 30 Nov

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About the job

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

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.

Apply on Capgemini