GMP Document Controller

Key Responsibilities

1. Manage and maintain the document management system (electronic and/or physical) for manufacturing, quality control and regulatory records;

2. Ensure compliance of all documentation processes with applicable standards and regulations, including Good Manufacturing Practice (GMP), FDA and ICH guidelines;

3. Ensure document integrity, including proper version control, security and traceability of all controlled documents;

4. Coordinate the review, approval and distribution of controlled documents (e.g., SOPs, batch records, protocols and training records);

5. Administer document lifecycle management, ensuring only current versions are in use and obsolete documents are properly archived or disposed of in accordance with retention policies;

6. Control document issuance and access, ensuring timely availability of accurate and approved documents to relevant personnel and stakeholders;

7. Track and monitor document workflows, including approvals, revisions and updates across departments;

8. Support audit readiness by preparing, organizing, and retrieving documentation for regulatory, quality and internal audits;

9. Provide training and guidance to staff on document control procedures, systems and compliance requirements;

10. Collaborate with cross-functional teams (QA, Production, Regulatory and Engineering) to ensure effective documentation practices; and

11. Undertake ad hoc and other duties as assigned from time to time.

Qualifications and Experience:

1. Malaysian citizens;

2. Minimum Bachelor’s Degree in Administration/Quality Management or any related field and recognized by the Malaysian government from a local or foreign higher education institution or a qualification recognized as equivalent;

3. Preferably with a minimum one (1) year of working experience in the Document Controller;

4. Strong communication, organizational and problem-solving skills;

5. Ability to work independently in a structured and regulated environment; and

6. Proficient in Microsoft Office (Word, Excel, Powerpoint).

Benefits and Opportunities Offered

At NIBM, we value our employees as the organisation’s most important asset. In this role, you will have the opportunity to:

Contribute to the development and management of the organisation’s human capital.

Work in a collaborative, dynamic environment that supports continuous learning.

Enjoy competitive rewards and compensation