Quality Improvement / Transformation
Review & Optimize
- Overall QC / QA operations with a view to streamline and simplify operations
- Core quality processes (e.g. deviations handling, root cause analysis &
CAPA, complaints, BMR review) - Current OOS / OOT approach & methodology including effective &
structured conduct of OOS / OOT investigations & report writing
Analyse
- Correct documentation & data
- Invalidation practice processes
Conduct
- GLP / GMP training programmes across the organization with specific
emphasis on the following: Key elements of good laboratory practices,
good chromatographic practices, failure investigations, invalidation of
data, data security, integrity and traceability, good documentation
practices, authority inspections and expectations