Responsible for routine monitoring of Manufacturing Areas.
Responsible for the routine GMP Inspection & review of Quality Records of other departments.
To monitor and ensure compliance level of organization is as per current GMP requirement
Good Documentation recording and updation.
Responsible for review of URS, DQ and vendor / suppliers documents related to qualification.
Responsible for preparation of Validation / Qualification protocol and report.
Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities.
Responsible for adequacy of execution of validations being carried out at prescribed procedures.
Responsible For Assurance Of Calibrations Before Performing Qualifications.
Responsible to co-ordinate with cross functional department personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.