JUNIOR ASSOCIATE

Department Details

Role Summary

Well versed on Sterility assurance, Aseptic Process Oversight and Process Compliance.

Co-ordinate and ensure on the execution of environmental monitoring in the Production Drug

Product and Production Drug Substance Cleanroom areas according to the schedule and approved

procedures. Lead investigation / deviation pertaining to area excursion. Review the environmental

monitoring test report (routine and non-routine) and trend data. Ensure procedure are in line with

cGMP and regulatory guidelines.

• Lead team in regulatory audits
• Co-ordinate and involve in Media Fill Run for Drug Product.
• Co-ordinate and ensure on the execution of gowning qualification / re-qualification

for PDP Cleanroom areas.

microbiological activities and reporting on the test results.

to environmental monitoring is maintain.

verification

Key Responsibilities

Well versed on Sterility assurance, Aseptic Process Oversight and Process Compliance.

Co-ordinate and ensure on the execution of environmental monitoring in the Production Drug

Product and Production Drug Substance Cleanroom areas according to the schedule and approved

procedures. Lead investigation / deviation pertaining to area excursion. Review the environmental

monitoring test report (routine and non-routine) and trend data. Ensure procedure are in line with

cGMP and regulatory guidelines.

for PDP Cleanroom areas.

microbiological activities and reporting on the test results.

to environmental monitoring is maintain.

verification

Educational Qualifications

Required Education Qualification :

Required Experience : 7 - 10 years