Executive, QA Validation

As a Validation Specialist, your role involves reviewing URS, DQ, and vendor/suppliers documents related to qualification. You will be responsible for preparing and reviewing Validation/Qualification protocols and reports. Your duties also include executing and reviewing Qualification/Re-Qualification and Validation activities of Equipment/System/Facility and Plant utilities. Coordinating with manufacturing, Engineering, and QC personnel for timely completion of Qualification/Validation/Re-qualification activities is a key aspect of your role. Additionally, you will be preparing and reviewing media fill and hold time protocols and reports. Your responsibilities extend to preparing Standard Operating Procedures for the Quality Assurance Department, assessing Change Control, Deviation, CAPA, Investigation, etc. You will also prepare protocols for process validation and cleaning verification/validation and conduct sampling activities as per the protocols. Risk assessment activities related to equipment/process/facility/system will be part of your duties, along with updating the Annual Validation Planner. Reviewing master and executed documents of cross-functional teams, master batch documents, different type planner, and calibration certificates are also within your purview. Monitoring cGMP compliance at the shop floor is another essential task. Qualifications: - Qualification: M.Sc/B.Pharm/M.Pharm - Experience: 2-5 years You should have experience in Validation for an Injectables plant, with a background in working in regulated industries, including US and/or Europe markets. Additional activities beyond your defined job responsibilities are expected to be performed as per the requirement of the HOD, following their instructions and guidance.,