To develop and asses the formulas ,Risk assessment handling ,Deviation handling, Change control handling
Must have QA experience in various formulations like tablets, capsules, liquid orals, ointments & creams etc.
QA experience in sterile/ parenteral products essential.
Exposure to deal with FDA and well versed with D&C Rules & Act, WHO GMP requirements, ICH guidelines etc.
Exposure to international regulatory audits is essential.
Must be well versed with quality management system such as Change management, Deviation management, OOS, OOT
Handling product complaints & recalls etc.
Exposure to RM PM vendor audits and C&FA audits and SAP is desirable.