QMS & DMS System Owner

Summary: The QMS & DMS System Owner is responsible for administering and maintaining controlled documents within a regulated environment, ensuring compliance with quality standards. This role involves coordinating document lifecycle activities, supporting quality systems, and collaborating with various stakeholders to facilitate timely updates and approvals. The position also requires monitoring quality metrics and providing user support for quality management systems. The role is remote and based in India.

Key Responsibilities:

• Administer and maintain controlled documents including SOPs, work instructions, policies, forms, and quality records.
• Coordinate document lifecycle activities including creation, review, approval, training, revision, archival, and retirement.
• Support quality systems such as Document Management, Change Control, CAPA, Deviations, Training Management, Audit Management, and Supplier Quality.
• Review document change requests and assess impact on existing quality processes.
• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, and business stakeholders to ensure timely document updates and approvals.
• Maintain compliance with GMP, GxP, FDA, EU, and internal quality standards.
• Support internal audits, external audits, and regulatory inspections by providing required documentation and evidence.
• Monitor quality metrics, generate reports, and identify opportunities for continuous improvement.
• Provide user support, training, and guidance on QMS and DMS processes and tools.
• Ensure accurate record retention, document traceability, and inspection readiness at all times.

Key Skills:

• Bachelor's degree or equivalent experience.
• Experience supporting QMS and DMS environments in regulated industries.
• Knowledge of GMP, GxP, CAPA, Change Control, and document control processes.
• Experience with electronic quality systems such as Veeva Vault, TrackWise, MasterControl, SAP DMS, or similar platforms.
• Strong communication and organizational skills.

Salary (Rate): undetermined

City: undetermined

Country: India

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

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Key Responsibilities:

• Administer and maintain controlled documents including SOPs, work instructions, policies, forms, and quality records.
  * Coordinate document lifecycle activities including creation, review, approval, training, revision, archival, and retirement.
  * Support quality systems such as Document Management, Change Control, CAPA, Deviations, Training Management, Audit Management, and Supplier Quality.
  * Review document change requests and assess impact on existing quality processes.
  * Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, and business stakeholders to ensure timely document updates and approvals.
  * Maintain compliance with GMP, GxP, FDA, EU, and internal quality standards.
  * Support internal audits, external audits, and regulatory inspections by providing required documentation and evidence.
  * Monitor quality metrics, generate reports, and identify opportunities for continuous improvement.
  * Provide user support, training, and guidance on QMS and DMS processes and tools.
  * Ensure accurate record retention, document traceability, and inspection readiness at all times.

Requirements:

* Bachelor's degree or equivalent experience.
* Experience supporting QMS and DMS environments in regulated industries.
* Knowledge of GMP, GxP, CAPA, Change Control, and document control processes.
* Experience with electronic quality systems such as Veeva Vault, TrackWise, MasterControl, SAP DMS, or similar platforms.
* Strong communication, organizatio

Reference
CR/134762_1780497289

Date
3 Jun 2026

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