Senior Officer, Documentation & GMP

Job Description: You will be responsible for commercial batch release to market and in-process Quality Assurance activities. This includes conducting in-process Quality Assurance checks during Manufacturing, packing operations, and line clearance of manufacturing, packing, and dispensing activities. Additionally, you will assure cleaning, sterilization, and aseptic manipulations of components, as well as sampling of Cleaning Validation & Compilation of the records. You will also be responsible for Sampling & compilation of Process Validation Reports (PVRs) and sampling and coordination during validation studies (process / cleaning validation). Routine monitoring of Manufacturing Areas, good Documentation recording, and updation will be part of your responsibilities. You will review Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs) and conduct routine GMP Inspection & review of Quality Records of other departments. In addition, you will monitor Aseptic process simulation study, prepare and compile Media Fill Protocol, Report, and be involved in the initiation of Change Control, Deviation, and Failure Investigation. Environmental monitoring (Viable) in liquid, lyophilized, and dry powder manufacturing areas, preparation and implementation of SOP's, viable monitoring in clean area of manufacturing and warehouse, personnel monitoring, and participation in qualification, requalification, area qualification activities, as well as calibration certificate review and approval will also be part of your role. About Us: Amneal is an equal opportunity employer that values diversity and inclusion, fostering a workplace that does not discriminate based on caste, religion, gender, disability, or any other legally protected status. About The Team: The Human Resources team at Amneal partners with all aspects of the organization, driving success through effective and innovative people management for both current and future business needs. Key Roles That The Human Resources Team Performs: - Executive Role: Specialists in all aspects of people management providing high-level input at a strategic level into all key business decisions. - Audit Role: Ensures compliance with legal requirements and best practice employment policies and procedures. - Facilitator Role: Supports, advises, and extends the ability of all areas of the organization to meet their objectives through effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. - Consultancy Role: Provides expert advice on workforce management, employee relations, and performance. - Service Role: Ensures readiness to deal with developments impacting employment matters, such as changes in legislation and characteristics of the labor market.,