About the role
1. Documentation Control
- Prepare, review, and maintain SOPs, logbooks, equipment history
cards, calibration and preventive maintenance records.
- Ensure timely issuance, retrieval, and archival of controlled
documents.
- Maintain updated plant drawings, utility schematics, and equipment
lists.
- Ensure maintenance records are in compliance with WHO GMP, GDP, and
internal quality policies.
2. Compliance & Regulatory Support
- Align all maintenance documentation practices with WHO GMP and
applicable regulatory requirements.
- Coordinate with the QA department for document approvals and change
control.
- Prepare documentation required for internal, external, and
regulatory audits.
- Implement corrective and preventive actions (CAPA) related to
documentation gaps.
3. Coordination & Reporting
- Liaise with maintenance engineers and technicians to ensure timely
completion of equipment records.
- Maintain documentation for calibration schedules, breakdown
reports, preventive maintenance plans, and service reports.
- Prepare monthly maintenance compliance reports and submit to
management.
4. Training & Continuous Improvement
- Conduct training sessions for maintenance staff on GDP and
documentation requirements.
- Participate in continuous improvement initiatives to streamline
documentation processes.
- Support implementation of electronic document management systems
(EDMS) if applicable.