Job highlights

- Qualifications : B Pharma / M Pharma / BE/B Tech .
- 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
- Experience : 8 to 12 Years .

- EXPERIENCE IN AUTOCAD
- Qualifications : B. Pharma/M. Pharma/BE/B. Tech
- Experience : 8 to 12 Years

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

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