Senior Officer, Quality Assurance

Job Description

Responsible for routine monitoring of Manufacturing Areas.

• Responsible for the routine GMP Inspection & review of Quality Records of other departments.
• To monitor and ensure compliance level of organization is as per current GMP requirement
• Good Documentation recording and updation.
• Responsible for review of URS, DQ and vendor / suppliers documents related to qualification.
• Responsible for preparation of Validation / Qualification protocol and report.
• Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities.
• Responsible for adequacy of execution of validations being carried out at prescribed procedures.
• Responsible for assurance of calibrations before performing qualifications.
• Responsible to co-ordinate with cross functional department personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
• Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
• Responsible to check production shop floor compliance.
• Responsible for preparation and review of VMP.
• Responsible for preparation, review, execution data and compilation updation of validation related documents.
• Responsible for handling of failures during qualification by using QMS tools.
• Responsible for Preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System.
• 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 certification 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

Risk Assessment, Documentation, Calibration