Document Control Coordinator - Life Sciences & Quality Compliance

Capgemini; Coimbatore District; In loco; INR 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

Capgemini Engineering in Coimbatore seeks a Document Control Coordinator to drive lifecycle activities for quality documents within Life Sciences. You will ensure accuracy, regulatory readiness, and coordination among owners, reviewers, approvers, and training teams in a controlled environment.

The role requires 4+ years in document control and quality operations, with hands-on experience in QA, QMS, and eDMS platforms.

Competenze

• 4+ years of experience in Document Control and Quality Operations.
• Experience in regulated industries (life sciences, pharma, medical devices).
• Knowledge of QMS and controlled document lifecycle.
• Familiarity with eDMS and regulatory inspections.
• Strong documentation accuracy and audit readiness.

Mansioni

• Execute new document creation, revisions, periodic reviews, publication, archival, retirement, and document lifecycle activities.
• Review documents for formatting standards, template compliance, metadata accuracy, version control, and completeness.
• Initiate, maintain, and monitor QMS workflows while coordinating with document owners, reviewers, approvers, and training teams.
• Maintain document control records, document numbering systems, workflow status, repository data, and audit trails.
• Track open requests, SLA commitments, and due dates, escalating risks and bottlenecks as required.
• Support document retrieval, traceability, regulatory inspections, audits, and evidence preparation activities.
• Generate KPI/SLA reports, backlog metrics, compliance dashboards, and process status reports.
• Ensure adherence to document management procedures while protecting data integrity and record accuracy.

Conoscenze

Document control

Quality assurance

Regulatory compliance

eDMS

Data integrity

Stakeholder coordination

Audit readiness

Formazione

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Medical Sciences, Engineering, Quality Management, or related

Strumenti

Veeva Vault

MasterControl

OpenText

TrackWise

Documentum

Descrizione del lavoro

Job Description

Document Control Coordinator - Life Sciences & Quality Compliance

Location :- Coimbatore

Experience :- 4+ 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 organizations strengthen quality compliance, ensure regulatory readiness, and drive operational excellence through robust document management and quality systems.

Your Role

As a Document Control Coordinator - Life Sciences & Quality Compliance, you will support the administration and execution of controlled quality documents across their lifecycle. You will ensure document accuracy, compliance with QMS procedures, audit readiness, and effective coordination between document owners, reviewers, approvers, and stakeholders in a regulated Life Sciences environment.

In this role, you will:

• Execute new document creation, revisions, periodic reviews, publication, archival, retirement, and document lifecycle activities.
• Review documents for formatting standards, template compliance, metadata accuracy, version control, and completeness.
• Initiate, maintain, and monitor QMS workflows while coordinating with document owners, reviewers, approvers, and training teams.
• Maintain document control records, document numbering systems, workflow status, repository data, and audit trails.
• Track open requests, SLA commitments, and due dates, escalating risks and bottlenecks as required.
• Support document retrieval, traceability, regulatory inspections, audits, and evidence preparation activities.
• Generate KPI/SLA reports, backlog metrics, compliance dashboards, and process status reports.
• Ensure adherence to document management procedures while protecting data integrity and record accuracy.

Your Profile

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Medical Sciences, Engineering, Quality Management, or a related discipline.
• 4+ years of experience in Document Control, Document Management, Quality Operations, Regulatory Support, Compliance, or related functions.
• Mandatory experience in Life Sciences, Pharmaceutical, Biotechnology, Medical Device, Healthcare, Medical, or other regulated industries.
• Hands‑on experience within Compliance, Regulatory Affairs, Quality Assurance (QA), Quality Systems (QMS), or regulated operational environments.
• Strong understanding of controlled document lifecycle management, records management, audit readiness, and data integrity principles.
• Experience working with Electronic Document Management Systems (eDMS) or controlled repositories such as:
  • Veeva Vault
  • MasterControl
  • OpenText / Documentum
  • TrackWise
  • Equivalent QMS/eDMS platforms

About Us

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 life sciences and healthcare innovation to advanced engineering 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.