Document Controller for Qms

**Job description**

**Responsibility**

The Quality Management System Document Control Coordinator (QMS DCC) is responsible for managing and maintaining the company’s document control system to ensure compliance with quality standards and regulatory requirements. This role involves organizing, maintaining, and distributing all quality management system documents and records, ensuring accuracy, accessibility, and proper version control.

**Scope**:

- **Document Management**:

- **Creation and Updates**: Develop, revise, and control documentation for the Quality Management System, including policies, standard operating procedures (SOPs), work instructions, and forms.
- **Storage and Organization**: Ensure all documents are accurately labeled, indexed, and stored in both electronic and hard copy formats in the document control system. Maintain an organized filing system that allows for easy retrieval of documents.
- **Version Control**:

- **Revision Tracking**: Implement and maintain a robust version control system that tracks changes and revisions to documents, ensuring traceability of all modifications.
- **Distribution**: Ensure that the latest approved versions of documents are distributed to relevant personnel and obsolete versions are removed from circulation and archived.
- **Compliance and Audits**:

- **Standards Adherence**: Ensure all documents comply with applicable quality standards (e.g., ISO 9001, ISO 13485, IATF 16949 GMP) and regulatory requirements.
- **Audit Support**: Prepare for internal and external audits by organizing necessary documentation and records. Facilitate auditors' access to documents and records during audits.
- **Audit Findings**: Assist in addressing audit findings related to document control and implement corrective actions as needed.
- **GMP (Good Manufacturing Practices) certification12345**:

- Ensures manufacturing processes meet high quality and safety standards.
- Demonstrates commitment to continuous improvement, customer satisfaction, and regulatory compliance.
- Describes minimum standards for medicines manufacturers.
- Ensures consistent production and control of medicinal products.
- Covers all aspects of the production process, from materials to equipment to staff
- **Training and Support**:

- **Training Programs: Develop and conduct training programs for staff on document control procedures, including the use of the document management system.**:

- **User Support: Serve as the primary point of contact for document control-related inquiries, providing guidance and support to ensure compliance and understanding of document control processes.**:

- **Continuous Improvement**:

- **Process Evaluation: Regularly evaluate document control processes to identify areas for improvement.**:

- **System Enhancements: Implement process improvements and system enhancements to increase efficiency, accuracy, and compliance. Utilize feedback from audits and users to refine document control practices.**:

- **Record Keeping**:

- **Approval Records: Maintain accurate records of document approvals, revisions, and distributions.**:

- **Retention Policy: Ensure proper retention and disposal of quality records in accordance with company policies and regulatory requirements. Establish and manage record retention schedules.**

**Qualifications**:

- **Education**:

- Bachelor’s degree in Quality Management, Business Administration, or a related field preferred.
- **Experience**:

- Minimum of 2 to 5 years of experience in document control or quality management, preferably in a regulated industry such as pharmaceuticals, medical devices, or manufacturing.
- Experience with QMS standards (e.g., ISO 9001,ISO 14001,ISO 13485,AS9100 ,IATF 16949) is highly desirable.

Pay: RM2,500.00 - RM3,200.00 per month