1 of 1 21 CFR Part 11 Jobs in the East of England

data integrity. Responsibilities Provide overall compliance oversight for all GxP computerised systems across Pharmanovia Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance Develop, implement and maintain computerised systems validation and lifecycle management processes … management of (CAPA, Deviation, Change Controls, Complaints, PQRs, Management Reviews, recalls, Strong knowledge of: Good Manufacturing Practice (GMP) and GxP EU Annex 11 21 CFR Part 11 GAMP 5 Data integrity principles and MHRA expectations Experience supporting or leading regulatory inspections and audits Required Skills ...