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.
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.
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.
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.