Qualifying new equipment, also up to PM to review/challenge or write the master validation plan (SME CSV).
Establishing a lean and efficient project verification approach (ASTM E2500).
Ensuring that any significant GMP and regulatory risks are appropriately mitigated and/or escalated to management.
Master’s Degree in Engineering, Bioengineering
5 to 8 years of experience in Qualification and Verification
Knowledge of GMP, CFR, Eudralex, GAMP
knowledge of Quality Risk Analysis