Preferred candidate profile
Must be aware of regulatory guideline like 21 CFR part 11, EUannex 11, GAMP 5 etc.
Must know about GAP assessment.
Must have exp in handling CSV of L1, L2 system like DAS, DCS, Empower, OSD /injectable Mfg equipment.
Must have knowledge for performing category 4 and 5 system.
Valuable communication skill, language - English, Hindi
Role & responsibilities
Preparation and execution of validation deliverables like IRA,VP, URS,FS, CS, DS, FRA, IQ, OQ, TM, VSR
Execution of qualification document without DI