1. Engineering QA
- Provide QA oversight for engineering, utilities, facilities, HVAC, water systems and critical GMP equipment.
- Review/approve URS, DQ, FAT/SAT, IQ, OQ, PQ and requalification documents.
- Review engineering-related Change Controls, Deviations, Investigations, CAPA and Risk Assessments.
- Ensure critical equipment and utilities remain in a qualified and compliant state.
- Review GMP impact of engineering modifications, maintenance and breakdowns.
- Support regulatory and customer audits related to Engineering and Utilities.
2. Quality Management System
- Manage and monitor key QMS elements including:
- Deviation Management
- CAPA
- Change Control
- Quality Risk Management
- Document Management
- Internal Audits / Self-Inspection
- Management Review
- Quality Metrics and Trending
- Periodic Review
- Inspection Readiness
- Review investigation reports and ensure appropriate root-cause analysis and effective CAPA.
- Monitor QMS timelines and ensure timely closure of actions.
- Identify recurring/systemic issues through trend analysis and drive continuous improvement.
- Ensure QMS procedures remain aligned with current GMP and regulatory expectations.
3. Training Management
- Manage the site's GMP Training System in coordination with QA and functional departments.
- Prepare and monitor the annual training calendar.
- Ensure timely completion of GMP, SOP, functional, OJT and compliance training.
- Review/approve training materials, including PPTs, OJT materials and learning capsules.
- Establish appropriate training content governance, version control and approval mechanisms.
- Ensure training effectiveness is evaluated where required.
- Monitor training compliance, overdue training and training metrics.
- Identify training gaps based on deviations, CAPA, audits, regulatory observations and QMS trends.
- Develop targeted GMP learning programs based on inspection and quality intelligence.