Position Summary
The Manufacturing Documentation Associate (Lighthouse) supports environmental monitoring, manufacturing documentation, audit readiness, and coordination of manufacturing activities while ensuring GMP compliance and operational efficiency.
Key Responsibilities
Documentation & Monitoring
- Monitor environmental conditions through Lighthouse during manufacturing activities.
- Document and review Lighthouse alarms and batch printouts.
- Issue, review, and maintain manufacturing documents, logbooks, and forms.
Manufacturing Support
- Coordinate documentation for visual inspection and packaging operations.
- Support departmental training activities.
- Perform assigned tasks as directed by the HOD.
Compliance & Audit Readiness
- Conduct GEMBA walks and maintain audit readiness across manufacturing lines.
- Ensure documentation complies with manufacturing and quality requirements.
Qualifications
Required
- Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
- 1-3 years of experience in pharmaceutical manufacturing or documentation.
- Strong organizational skills and attention to detail.
Preferred
- Experience with environmental monitoring systems.
- Knowledge of GMP documentation and audit requirements.
Key Competencies
- Environmental Monitoring
- Documentation Management
- GMP Compliance
- Audit Readiness
- Attention to Detail
- Organization & Planning
- Training Coordination
- Team Collaboration
What Success Looks Like
- Environmental monitoring and documentation are completed accurately and on time.
- Manufacturing records remain audit-ready and compliant.
- Visual inspection and packaging documentation are effectively coordinated.
- Manufacturing areas consistently meet inspection and compliance standards.
