Being the shift in charge, act as a first responder to production issues and concerns
Supervise activities in the respective shift, review batch record, logbooks and other records, guide the shift personnel to ensure activities and records are falling in line with GMP requirement
To monitor area and documentation compliance with Good Manufacturing Practice
To ensure availability, preparation and real time data entry in Batch Manufacturing Records, Checklist, Log Sheet and Equipment Cleaning Checklist
To prepare and execute equipment qualification and validation protocols for Buffer
To comply with EHS policies and procedures. To ensure safety practices are followed by all shift personal and contract labors
To ensure production deviation, OOS or OOT is reported, evaluated and investigated
To plan and coordinate maintenance and calibration of buffer equipment with Engineering and Instrumentation team
Responsible for OTIF execution of all activities related to Downstream-Buffer
To assist with planning of production schedule for unit operations
Data owner for process equipment used in day-to-day activity
Qualification:
Bachelor's degree in Chemical/ Bioprocess/ Biology OR any Science related courses
Years of Experience: 1-3 years
Shift Requirement: Yes, 3 rotational shifts (Shift allowance is provided)
Preferred Industry: Any industry (manufacturing/ production industry added advantage)