Head Quality is accountable for ensuring the all-time readiness of the plant for various GMP compliance audits, being the single point contact on all Quality matters.
Skills:
Manage GMP quality systems.
Conduct vendor audits and ensure compliance.
Maintain a GMP-compliant document control system.
Supervise investigations of non-conformances.
Ensure company readiness for regulatory inspections.
Implement a self-inspection program for EU GMP compliance.
Hold a scientific degree in pharmacy, pharmaceutical sciences, or a related field.
Bring 15+ years of QA & QC experience.
Have exposure to API manufacturing plants.
Worked on greenfield projects and handled EU-GMP.
Implement quality systems in a GMP environment.
Direct experience with FDA and other health authority inspections.
Extensive knowledge of GMP compliance regulations, particularly EU-GMP.