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Blog Function: Quality Assurance & Documentation Reports to: Assistant General Manager Location: Andheri (HO) Responsibilities FACILITIES, UTILITIES, PROCESSES, CLEANING AND EQUIPMENTS, DOCUMENTATION AND IMPLEMENTATION

MASTER IN FDS, FAT AND SITE QUALIFICATION, COMMISSIONING AND VALIDATION DOCUMENTATION.

FACILITY COMMISSIONING AND INSTALLATION OF INJECTABLE LINE I.E. LIQUID & LYOPHILIZED

RESPONSIBLE FOR EXECUTION OF INSTALLATION, OPERATIONAL & PERFORMANCE QUALIFICATION OF EQUIPMENTS. RESPONSIBLE FOR REVIEW AND EXECUTION OF SIP VALIDATION, AUTOCLAVE VALIDATION, FREEZE DRYER (LYOPHILIZER), DEPYROGENATION TUNNEL AND VIAL FILLING, STOPPERING AND SEALING MACHINE WITH CRABS.

21 CFR COMPLIANCE AND COMPLAINT ENVIOURMENT

AUTOMATION INTEGRATION FROM PLC, SCADA, BMS.

AWARE ABOUT BMR - BATCH MANUFACTURING RECORD AND IMPLEMENTATION OF SAME WITH OSD, GRANULATION , INJECTABLE LINE EQUIPMENT’S.

UNDERSTANDING OF URS AND THE PROCESS FLOW DIAGRAM AND IMPLEMENTING IT IN THE QAP OF THE EQUIPMENT / SYSTEM TO BE MANUFACTURED.

ABILITY TO COMMENT ON THE FABRICATION DRAWING FOR THE REQUIREMENTS OF PROCESS AND SAFETY.

IFAT REPORT AND DEVIATION REPORTING,



MAKING SNAG LIST AND INVESTIGATION OF PROCESS DEVIATION / COMPLIANCES MISSED DURING MANUFACTURING TO THE ROOT CAUSE ANALYSIS.

CONTROLLING OF DOCUMENTATION APPROVAL FROM CLIENT / CONSULTANT IN LINE WITH PROCESS VALIDATION AND CLEANING VALIDATION.

MAKING THE QUALIFICATION PROTOCOLS i.e., DQ, FAT, SAT, IQ, OQ, PQ FOR STANDARDIZATION TEMPLATE FOR ALL EQUIPMENT / SYSTEM. THESE TEMPLATES AS CONTROLLED COPY AND RELEASE VERSION TO APPOINTED VENDOR TO COMPLY.

LEADING CHANGE CONTROL, DEVIATION & CAPA IN THE DEPARTMENT.

SAMPLING OF VALIDATION BATCHES & COMPILATION OF REPORT.

VENDOR QUALIFICATION INPUTS FOR SELECTION OF VENDOR BASED ON ITS TECHNICAL CAPABILITIES AND MANUFACTURING CAPACITIES.

PREPARATION & REVIEW OF SOP FOR QC PROCESS AND ITS WBS.

CLEAN ROOMS, HVAC, BLACK UTILITIES AND CLEAN UTILITIES VALIDATION PROTOCOL AND INTERNAL FAT PROTOCOL / REPORT MAKING.

MANAGE ISO QUALIFICATIONS ISSUES AND MAINTAIN ALL OFFICIAL DOCUMENTATION.

EXPERIENCE IN AUTOCAD. AND ERP FOR QC STAGE – APPROVAL / DISAPPROVAL Certification / Training In Areas Of USFDA, MHRA, ANVISA, TGA, WHO, MOHAP-UAE, ISO-QMS/EMS & OHSMS

📌 Documentation Manager Mumbai (India)
🏢 Fabtech Technologies
📍 India