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7 Fabtech Technologies International Jobs
Documentation Manager
Fabtech Technologies International
posted 3mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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
Employment Type: Full Time, Permanent
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What people at Fabtech Technologies International are saying
What Fabtech Technologies International employees are saying about work life
based on 110 employees
Flexible timing
Alternate Saturday off
No travel
Day Shift
Fabtech Technologies International Benefits
Job Training 
Soft Skill Training 
Team Outings 
Health Insurance 
Free Transport 
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