Regulated Document Management Specialist (Life Sciences or Tobacco

Capgemini Engineering; Coimbatore District; On-site; INR 600,000 - 900,000; Full time

Job summary

Capgemini Engineering in Coimbatore seeks a Regulated Document Management Specialist with 2+ years of experience in Life Sciences regulatory documentation. You will manage controlled documents from creation to retirement and support QA, Regulatory, and Manufacturing teams to ensure traceability and audit readiness.

You'll administer workflows, metadata, version control, retention, and archival while coordinating reviews, supporting regulatory inspections, and system transitions.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, or related.
• 2+ years in Document Management, QA, Compliance, Regulatory Ops, or Quality Systems.
• Knowledge of QMS, controlled documentation, audit readiness, data integrity.

Responsibilities

• Manage controlled documents from creation through retirement.
• Administer workflow, metadata, version control, retention, and archival.
• Perform quality reviews for completeness, traceability, and compliance.
• Coordinate reviews with Quality, Regulatory, Manufacturing, Training, and R&D.
• Support regulatory inspections, audits, CAPA, change control, and transitions.

Skills

Quality Assurance

Regulatory Compliance

Audit Readiness

Document Lifecycle

Stakeholder Coordination

Education

Life Sciences

Pharmacy

Engineering

Tools

Veeva Vault

OpenText/Documentum

MasterControl

TrackWise

SharePoint

Job description

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 DescriptionRegulated Document Management SpecialistLocation :- CoimbatoreExperience :- 2+ YearsChoosing 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 RoleAs 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 ProfileBachelor'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 UsAt 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.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.