Responsibilities:
1. Supports the QC Managers to ensure QC planning and resources are aligned to the project and supply chain forecasts.
2. Contributes to innovations and improvement projects across QC. To participate in site improvement projects, where required, to drive quality decisions and to provide advice and technical support when required.
3. To ensure the timely completion of DR’s and CAPA’s and progression of Change Controls to support the QC laboratories. To ensure SOP updates are completed when required for either continual improvement or when due for periodic review.
4. To ensure QC critical KPI’s, HSE and cGMP activities are tracked, trended and displayed consistently across QC.
5. Ensure compliance with client Policies.
6. To ensure timely completion of technical reports.
7. Management of QC CAPEX projects.
Accountability:
- To collate data relating to site and organisational changes that will impact the efficient running of the laboratories.
- Manage the completion of DR’s, CAPA’s, Change Controls and SOP updates working closely with the QC labs.
- Attendance at and presentation at DRB.
- CAPEX project submissions and management.
- Invalid reporting.
- Maintenance of QC metrics.
- PPS problem solving.
Knowledge & Skills:
cGMP background in the Pharmaceutical industry
Knowledge and understanding of Lean Lab principles
Good understanding of the QC labs. Experience of Quality Control / Microbiological testing techniques and industry practices
Knowledge of continuous improvement techniques and advanced root cause analysis techniques
Report writing skills
Proven time management skills
Proven communication skills both written and verbal