ideal candidate must have exposure to qa qc and or production functions in a reputed pharma chemical , agro chemical or api manufacturing company
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.
Exposusre 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.