- Start-To-Finish

- Solutions For Air

- Solutions For Water

- Solutions For Process

- Case Studies

- Projects

- 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)
🏢 Fabtech Technologies
📍 Mumbai