The Document Control Custodian is responsible for maintaining organized, accurate, and up-to-date documentation for the plant. This role coordinates all document control activities, ensures proper data entry in standard registers, and supports internal and external audits. The position also handles FDA Portal applications and ensures that the Certificate of Product Registration (CPR) is valid and compliant at all times.
Duties and Responsibilities
- Maintain and manage plant documentation (e.g., policies, procedures, contracts, and controlled records) to ensure accuracy, accessibility, and compliance with ISO, IMS, and applicable regulatory standards.
- Oversee document control processes, including document filing, record retention, and monthly monitoring of permits, certificates, and licenses.
- Coordinate customer satisfaction surveys, subcontractor performance evaluations, and follow-up on corrective actions from audit findings.
- Prepare reports, conduct orientation or training sessions, and assist management in implementing company goals and continuous improvement programs.
- Process FDA applications for product registration and licensing, including monitoring application status, addressing deficiencies, and ensuring timely compliance.
- Support internal communication within the plant and facilitate visitor orientation, including other administrative duties as may be assigned.
Qualifications
- Bachelor's degree in Industrial Engineering, or any related course.
- At least a year of relevant work experience in documentation control or regulatory compliance, preferably in a manufacturing or food processing environment.
- Familiarity with ISO standards, Integrated Management Systems (IMS), and FDA regulatory requirements is highly desirable.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
- Strong attention to detail, organizational skills, and ability to manage confidential information.
- Effective written and verbal communication skills.
- Ability to work independently and manage multiple tasks in a fast-paced environment.
- Experience with FDA Portal systems and monitoring of CPRs is an advantage.
