Regulated Document Management Specialist
Capgemini · Coimbatore · onsite · Posted today
Undisclosed2–7 yrsfulltimeSourced from
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About this role
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
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.
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.
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Skills
opentextDocument ManagementauditsDocumentumCAPAChange ControlmetadataPharmacydata reconciliationBiotechnologyMicrobiologyHealthcareManufacturingoperationsmaintenancecompliancePharmaceuticalLife Sciences
About Capgemini
Capgemini
IT Services & Consulting
235k+
employees
1967
59 years old
Mumbai, Maharashtra
India
About
Capgemini is an AI-powered global business and technology transformation partner, delivering tangible business value.
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