Coimbatore Regulated Document Management Specialist (Life SciencesTobacco

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 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. 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. Ref. code: 572618 Posted on: 23 Oct 2026 Experience Level: Experienced Professionals Contract Type: Permanent Location: Coimbatore, IN Brand: Capgemini Engineering Professional Community: Products & Systems Engineering Apply now » Apply Now Start applying with LinkedIn Please wait... Find similar jobs: All rights reserved by Capgemini. Copyright © 2025 Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. 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