Regulated Document Management Specialist

Capgemini; Coimbatore District; In loco; INR 700.000 - 1.100.000; Tempo pieno

Descrizione del lavoro

Capgemini Engineering in Coimbatore is seeking a Regulated Document Management Specialist to oversee lifecycle processes for controlled documents in life sciences sectors. You will collaborate with Quality, Regulatory, Manufacturing, R&D, and Training teams to ensure accuracy, traceability, and audit readiness.

Ideal candidates have 2+ years of experience in regulated documentation, familiarity with QMS, and exposure to eDMS platforms.

Competenze

• Bachelor's degree in Life Sciences or related discipline.
• Minimum 2+ years in Document Management, Quality Assurance, Compliance, Regulatory Operations, or Quality Systems in a regulated industry.
• Strong understanding of Life Sciences industry requirements and quality compliance.
• Experience with QMS, controlled documentation, audit readiness, and data integrity.

Mansioni

• Manage controlled documents from creation through retirement (SOPs, forms, records).
• Oversee document lifecycle, metadata, version control, retention, and distribution.
• Perform quality reviews for completeness, traceability, and regulatory compliance.
• Coordinate reviews with Quality, Regulatory, Manufacturing, Training, and R&D teams.
• Support inspections, audits, and data reconciliation during system transitions.
• Monitor status, aging reports, review cycles, and workflow metrics.

Conoscenze

Document Management

Quality Assurance

Regulatory Operations

Quality Systems

Data integrity

Audits

Formazione

Bachelor's degree in Life Sciences or related discipline

Strumenti

eDMS platforms (Veeva Vault, OpenText/Documentum, MasterControl, TrackWise, SharePoint)

Descrizione del lavoro

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.