QA Executive (DCC) Document Control

Bliksen Sdn Bhd; Kulai; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading document control organization in Johor, Malaysia is seeking a dedicated Document Control Officer to oversee the management and compliance of the document management system. The ideal candidate will have over 5 years of experience and will ensure that all documents are accurately created, reviewed, and stored according to regulatory standards. Additional responsibilities include conducting audits, providing training, and collaborating across teams. Benefits include EPF, SOCSO, and various types of leave.

Benefits

EPF

SOCSO

Annual Leave

Medical Leave

Compassionate Leave

Qualifications

• 5+ years of experience in document control or management.
• Strong knowledge of ISO 9001 and GMP standards.
• Experience with auditing document control processes.

Responsibilities

• Maintain and control the document management system.
• Manage the document lifecycle including compliance with standards.
• Conduct audits to ensure correct documentation practices.

Skills

Document management

ISO 9001 compliance

GMP knowledge

Data integrity

Cross-functional collaboration

Job description

Maintain and control the organization's document management system, ensuring documents are accurately created, reviewed, approved, and distributed according to established procedures.

Manage document lifecycle, including creation, revision, storage, retrieval, and archival, adhering to regulatory requirements and company policies.

Implement and maintain document control processes to ensure compliance with ISO 9001, GMP, or other relevant quality standards.

Conduct regular audits of document control processes to identify areas for improvement and ensure ongoing compliance.

Provide training and support to employees on document control procedures and best practices.

Assist in the preparation for and management of internal and external audits related to document control.

Manage and maintain databases for tracking and controlling documents, ensuring data integrity and accuracy.

Prepare, review, and revise controlled documents, including standard operating procedures (SOPs), work instructions, and forms.

Collaborate with cross-functional teams to ensure document control requirements are integrated into all relevant processes.

Requirement

• Maintain and control the organization's document management system, ensuring documents are accurately created, reviewed, approved, and distributed according to established procedures.
• Manage document lifecycle, including creation, revision, storage, retrieval, and archival, adhering to regulatory requirements and company policies.
• Implement and maintain document control processes to ensure compliance with ISO 9001, GMP, or other relevant quality standards.
• Conduct regular audits of document control processes to identify areas for improvement and ensure ongoing compliance.
• Provide training and support to employees on document control procedures and best practices.
• Assist in the preparation for and management of internal and external audits related to document control.
• Manage and maintain databases for tracking and controlling documents, ensuring data integrity and accuracy.
• Prepare, review, and revise controlled documents, including standard operating procedures (SOPs), work instructions, and forms.
• Collaborate with cross‑functional teams to ensure document control requirements are integrated into all relevant processes.

Responsibility

• Maintain and control the company's document management system (DMS) to ensure documents are accurately stored, easily retrievable, and properly version controlled.
• Manage the document lifecycle, including creation, review, approval, distribution, revision, and obsolescence of controlled documents (e.g., SOPs, work instructions, forms, specifications, and records).
• Ensure compliance with relevant regulatory requirements (e.g., ISO 9001, GMP) and internal quality standards related to document control and data integrity.
• Conduct regular audits of the DMS and controlled documents to identify and address any gaps or inconsistencies in documentation practices.
• Provide training and support to employees on document control procedures, including document creation, revision, approval workflows, and proper record‑keeping practices.
• Collaborate with cross‑functional teams (e.g., Quality Assurance, Production, Engineering) to develop, review, and update controlled documents to reflect current processes and best practices.
• Manage and maintain the company's training records, ensuring that all employees have completed required training on relevant procedures and regulations.
• Assist in the preparation for and support internal and external audits related to document control and quality management systems.
• Generate reports and metrics on document control activities, such as document approval cycle times, document revision rates, and training completion rates, to identify areas for improvement.

Benefits

• EPF
• SOCSO
• Annual Leave
• Medical Leave
• Compassionate Leave