Senior Officer, Quality Assurance

You will be responsible for routine monitoring of Manufacturing Areas and conducting routine GMP Inspection & review of Quality Records of other departments. Your role will involve monitoring and ensuring that the compliance level of the organization is in line with current GMP requirements. Good Documentation recording and updation will be a crucial part of your responsibilities. Key Responsibilities: - Reviewing URS, DQ, and vendor/suppliers documents related to qualification - Preparing Validation/Qualification protocols and reports - Executing and reviewing qualification/re-qualification and validation activities of Equipment/System/Facility and Plant Utilities - Ensuring adequacy of execution of validations as per prescribed procedures - Assuring calibrations before performing qualifications - Coordinating with cross-functional department personnel for timely completion of Qualification/Validation/Re-qualification activities - Preparing Standard Operating Procedures of Quality Assurance Department - Checking production shop floor compliance - Preparing and reviewing VMP - Preparing, reviewing, executing data, and compiling updation of validation-related documents - Handling failures during qualification using QMS tools - Preparing, reviewing, and executing risk assessment activities related to Equipment/Process/Facility/System - Monitoring clean areas of manufacturing and warehouse as per the defined schedule - Personnel monitoring - Participating in qualification, requalification, area qualification activities - Reviewing and approving calibration certifications Amneal is an equal opportunity employer that values diversity and inclusion. They do not discriminate based on caste, religion, gender, disability, or any other legally protected status.,