Job Description

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.

Key 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

Qualifications

• Diploma or Bachelor’s degree in a relevant field (preferred)

Experience

• 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.

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Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.