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Document Control Coordinator (EMEA Timezone : 3pm - 12am MYT)

External
resmed logoResmed · Johor Bahru, Malaysia
Full-timeOn-siteToday
ComplianceDocumentationGCPLess
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Responsibilities

  • Document Control & Systems Management
  • Maintain and administer the document control system, ensuring accuracy, traceability, and compliance with company and regulatory requirements
  • Manage document lifecycle processes including creation, review, approval, distribution, revision, and archival
  • Ensure proper security, storage, and retrieval of quality records and documentation
  • Engineering Change Management
  • Implement and maintain the Engineering Change Notice (ECN) system
  • Coordinate documentation updates related to product improvements and new product development
  • Ensure all changes are correctly documented, approved, and communicated across relevant stakeholders
  • Regulatory & Quality Compliance
  • Support compliance with applicable regulations and standards (e.g., GMP, GLP, GCP where applicable)
  • Assist in preparing and maintaining quality documentation such as SOPs, procedures, and records
  • Support internal and external audits by ensuring documentation is complete and up to date
  • Cross-Functional Coordination
  • Liaise with Engineering, Manufacturing, Operations, and other teams to ensure documentation accuracy and completeness
  • Act as a point of contact for document-related queries and support internal stakeholders
  • Continuous Improvement
  • Identify opportunities to improve document control processes and systems
  • Support quality initiatives and contribute to process improvements within the QA function

Requirements

  • Diploma or Bachelor's degree in a relevant field (preferred)
  • Minimum 2 years of experience in document control, quality assurance, or similar roles
  • Experience in regulated industries (e.g., medical devices, pharmaceuticals, manufacturing) is an advantage
  • Skills & Competencies
  • Good understanding of document control processes and quality systems
  • Familiarity with regulatory standards such as GMP/ISO (preferred)
  • Strong attention to detail and organizational skills
  • Ability to manage multiple tasks and handle non-routine situations independently
  • Good problem-solving skills with the ability to identify key issues from complex or incomplete information
  • Effective communication skills and ability to work collaboratively across teams
  • Additional Information
  • Able to work independently while also supporting team members with less experience
  • Serves as an informal resource for colleagues within the function.
  • #LI-APAC

Benefits

Health insuranceVision insurance

Additional Information

Role Overview The Document Controller plays a key role within the Quality Assurance (QA) function, supporting the maintenance, control, and integrity of quality documentation and systems. This role ensures compliance with regulatory requirements and internal quality standards, while supporting engineering changes, product development, and continuous improvement initiatives. The position works closely with cross-functional teams including Engineering, Manufacturing, Regulatory Affairs, and Operations to ensure accurate and timely documentation management.


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