Senior Officer, Documentation & GMP

Job Description

Responsible for commercial batch release to market

• Responsible for in process Quality Assurance activities.
• Responsible for In process Quality Assurance checks during Manufacturing, packing operations.
• Responsible for line clearance of manufacturing, Packing and dispensing activities
• Responsible for assurance of cleaning, sterilization and aseptic manipulations of components.
• Responsible for Sampling of Cleaning Validation & Compilation of the records.
• Responsible for Sampling & compilation of Process Validation Reports (PVRs)
• Responsible for sampling and coordination during validation studies (process / cleaning validation).
• Responsible for routine monitoring of Manufacturing Areas.
• Good Documentation recording and updation.
• Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs).
• Responsible for the routine GMP Inspection & review of Quality Records of other departments.
• Responsible for monitoring in Aseptic process simulation study.
• Responsible for Preparation and Compilation of Media Fill Protocol , Report.
• Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation.
• Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas
• Responsible for preparation and implementation of SOP's
• Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
• Responsible for personnel monitoring.
• Responsible to participate in qualification, requalification, area qualification activities.
• Calibration certificate review and approval

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role : Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role : Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role : Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role : Provide expert advice to the organization and it's managers on any aspect of workforce management and employee relations and performance.

Service Role : Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

Skills Required

Cleaning Validation, Environmental Monitoring, Process Validation, Documentation, Quality Assurance