Key Responsibilities: • Responsible for review of URS, DQ and vendor/ supplier’s 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 clearing validation etc.). • Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system. • Responsible for preparation and updation of Annual Validation Planner. • Responsible for review of the master and executed documents of cross functional team (CFT). • Responsible for review of master batch documents. • Responsible to review the different type planner and calibration certificates. • Responsible to monitor cGMP compliance at shop floor. • Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance. Qualification: M.Sc / B.Pharm / M.Pharm Experience: 2-5 years Requires experience in Validation for Injectables plant with experience of working in regulated industry including US and/or Europe markets.