Review and approval/certification of all validation protocol IQ, OQ, PQ and PV to meet validation and regulatory requirements.
Team lead for review of all validation documents related process equipments.
Review of submission packages to the regulator
Highly Technical Competent, Knowledge of Quality Process of Injectable unit.
Shall have exposure to regulatory audits like USFDA, MHRA, ANVISA, TGA etc.
Can guide and lead the team of QA and face the regulatory inspection independently.