Role & responsibilities
Protocol & Reporting: Prepare, review, and execute Cleaning Validation Master Plans (CVMP), protocols, and summary reports.
risk Assessment: Conduct Quality Risk Assessments (QRA) to identify hard-to-clean areas and determine re-validation frequencies.
ross-functional Coordination: Liaise with Production for equipment downtime, QC for sample analysis, and Engineering for CIP/SIP system cycles.
Audit Readiness: Act as a Subject Matter Expert (SME) during regulatory inspections (USFDA, MHRA, EDQM) to defend cleaning philosophies and data.
QMS Management: Handle deviations, CAPAs, and Change Controls related to cleaning failures or equipment modifications.
Education: B.Pharm / M.Pharm
Experience: 3 10 years of core experience in Cleaning Validation within a regulated pharmaceutical plant.
Soft Skills: Solid technical writing, analytical thinking, and the ability to work under tight manufacturing deadlines.