Description:
Position: Maintenance Executive (Documentation)
Location: Vapi
Experience: 1 - 3 Years
Industries: Pharma - API
Responsibilities:
- Documentation Management
- Prepare, review, and maintain maintenance-related documents such as:
- Standard Operating Procedures (SOPs)
- Preventive Maintenance (PM) schedules
- Breakdown maintenance records
- Equipment history cards
- Maintenance logbooks
- Calibration records
- Utility maintenance records
- Control issuance, revision, archival, and retrieval of engineering documents.
- Compliance & Regulatory Support
- Ensure documentation complies with:
- GMP (Good Manufacturing Practices)
- cGMP requirements
- Data Integrity guidelines
- Regulatory requirements from agencies such as US Food and Drug Administration, European Medicines Agency, and World Health Organization.
- Support internal and external audits by providing maintenance documentation.
- Assist in CAPA, deviation, change control, and investigation documentation related to engineering activities.
- Maintenance Coordination
- Track preventive maintenance schedules and ensure timely execution.
- Monitor pending maintenance activities and follow up with maintenance teams.
- Coordinate with production, quality assurance, and validation departments for documentation requirements.
- CMMS Management
- Update and maintain data in Computerized Maintenance Management Systems (CMMS).
- Generate maintenance reports, KPI reports, and compliance metrics.
- Ensure accuracy of equipment master data and maintenance records.
- Qualification & Validation Support
- Support equipment qualification activities (IQ/OQ/PQ documentation).
- Maintain records related to equipment installation, modification, and qualification.
- Reporting
- Prepare monthly maintenance documentation compliance reports.
- Track document closure status, overdue PMs, and audit observations.
- Present documentation metrics to management.
Required Skills
- Strong documentation and record management skills.
- Knowledge of maintenance systems and engineering processes.
- Familiarity with CMMS software.
- Understanding of equipment lifecycle documentation.
- Good communication and coordination skills.
Required Qualification: - Diploma/B.E/B.Tech - Mechanical/Electrical/Chemical
Pay: Up to ₹500,000.00 per year
Work Location: In person