Document Controller

11 hours ago

Senai, Malaysia SEIKO DENKI (M) SDN BHD Full time

**Job description**

**Responsibilities**

The QMS Document Control Coordinator is responsible for managing and maintaining the company’s document control system to ensure compliance with quality standards and regulatory requirements. This role ensures the integrity, accuracy, and accessibility of all Quality Management System (QMS) documentation and records.

**Scope of Work**

**1. Document Management**
- **Creation & Updates**: Develop, revise, and control QMS documentation, including policies, SOPs, work instructions, and forms.
- **Storage & Organization**: Ensure accurate labeling, indexing, and storage of documents in both electronic and hard copy formats. Maintain a structured filing system for efficient retrieval.

**2. Version Control**
- **Revision Tracking**: Implement and maintain robust version control systems for traceability of changes and revisions.
- **Distribution**: Ensure only current, approved documents are available to staff; remove and archive obsolete versions.

**3. Compliance & Audits**
- **Standards Adherence**: Ensure documentation aligns with applicable standards (e.g., ISO 9001, ISO 13485, IATF 16949, GMP).
- **Audit Support**: Organize and provide documentation during internal and external audits.
- **Audit Findings**: Assist in addressing and correcting document control-related audit findings.

**4. GMP Certification Support**
- Ensure compliance with GMP standards by maintaining documentation that supports quality and safety in manufacturing processes.
- Assist in demonstrating continuous improvement and adherence to minimum quality standards across production processes.

**5. Training & Support**
- **Training Programs**: Design and deliver training on document control procedures and the use of the document management system.
- **User Support**: Serve as the main contact for document control questions and guidance.

**6. Continuous Improvement**
- **Process Evaluation**: Periodically assess document control processes to identify and implement improvements.
- **System Enhancements**: Utilize audit feedback and user input to enhance systems for efficiency and compliance.

**7. Record Keeping**
- **Approval Records**: Maintain accurate documentation of approvals, revisions, and distributions.
- **Retention Policy**: Enforce document retention and disposal practices in line with company policies and regulatory requirements.

**QualificationsEducation**
- Bachelor’s degree in Quality Management, Business Administration, or a related field (preferred).

**Experience**
- 2-5 years of experience in document control or quality management, preferably in regulated industries such as pharmaceuticals, medical devices, or manufacturing.
- Strong working knowledge of QMS standards including:

- ISO 9001
- ISO 13485
- IATF 16949
- ISO 14001
- AS9100
- GMP

Pay: RM2,500.00 - RM3,300.00 per month

Schedule:

- Day shift

Supplemental Pay:

- Overtime pay

Work Location: In person

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