Executive, QA Validation

Job Description As a Validation Specialist, your key responsibilities will include: - Reviewing URS, DQ, and vendor/suppliers documents related to qualification. - Preparing and reviewing Validation/Qualification protocol and report. - Executing and reviewing Qualification/Re-Qualification and Validation activity of Equipment/System/Facility and Plant utilities. - Coordinating with manufacturing, Engineering, and QC personnel for respective Qualification/Validation/Re-qualification activity for timely completion of activities. - Preparing and reviewing media fill and hold time protocol and report. - Preparing Standard Operating Procedures of Quality Assurance Department. - Assessing Change Control, Deviation, CAPA, Investigation, etc. - Preparing protocols of process validation and cleaning verification/validation. - Conducting sampling activity as per the protocols (Process validation and clearing validation, etc.). - Executing risk assessment activity related to equipment/process/facility/system. - Updating Annual Validation Planner. - Reviewing master and executed documents of cross-functional team (CFT). - Reviewing master batch documents. - Reviewing different type of planner and calibration certificates. - Monitoring cGMP compliance at the shop floor. - Performing activities other than those defined in the Job responsibility as per the requirement of HOD, by following HODs instruction and guidance. Qualifications: - Qualification: M.Sc / B.Pharm / M.Pharm - Experience: 2-5 years You should have experience in Validation for Injectables plant with experience of working in regulated industry including US and/or Europe markets. As a Validation Specialist, your key responsibilities will include: - Reviewing URS, DQ, and vendor/suppliers documents related to qualification. - Preparing and reviewing Validation/Qualification protocol and report. - Executing and reviewing Qualification/Re-Qualification and Validation activity of Equipment/System/Facility and Plant utilities. - Coordinating with manufacturing, Engineering, and QC personnel for respective Qualification/Validation/Re-qualification activity for timely completion of activities. - Preparing and reviewing media fill and hold time protocol and report. - Preparing Standard Operating Procedures of Quality Assurance Department. - Assessing Change Control, Deviation, CAPA, Investigation, etc. - Preparing protocols of process validation and cleaning verification/validation. - Conducting sampling activity as per the protocols (Process validation and clearing validation, etc.). - Executing risk assessment activity related to equipment/process/facility/system. - Updating Annual Validation Planner. - Reviewing master and executed documents of cross-functional team (CFT). - Reviewing master batch documents. - Reviewing different type of planner and calibration certificates. - Monitoring cGMP compliance at the shop floor. - Performing activities other than those defined in the Job responsibility as per the requirement of HOD, by following HODs instruction and guidance. Qualifications: - Qualification: M.Sc / B.Pharm / M.Pharm - Experience: 2-5 years You should have experience in Validation for Injectables plant with experience of working in regulated industry including US and/or Europe markets.