Equipment qualification Engineer

Job description

Roles and Responsibilities • Develop and execute equipment qualification protocols (IQ, OQ, PQ) according to regulatory requirements. • Conduct risk assessments and implement corrective actions (CAPA) as necessary. • Collaborate with cross-functional teams to ensure compliance with QRM principles and 21 CFR Part 11 regulations. • Perform validation activities for new equipment installations, including verification of software and hardware functionality. • Ensure timely completion of all equipment qualification tasks within budgeted timeframes. Desired Candidate Profile • 4-8 years of experience in Equipment Qualification/Validation role in Pharmaceutical industry. • Bachelor's degree in B.Pharma or M.Pharma from a recognized institution. • Strong understanding of GMP guidelines, QRM principles, and 21 CFR Part 11 regulations. • Proficiency in developing IQ/OQ/PQ protocols, conducting risk assessments, implementing CAPAs.