Job Description
Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification.
Responsible for preparation and review 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 to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities
Responsible for preparation and review of media fill and hold time protocol and report.
Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc..
Responsible to prepare protocols of process validation and cleaning verification/validation.
Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..)
Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system
Qualifications
M.sc / B.pharm / M.pharm
