Assistant Manager, QMS | Change Control

Role Overview: You will be responsible for reviewing and approving change control requests raised by cross-functional teams. You will assess the GMP, regulatory, and quality impact for process, equipment, documents, and systems. Your role will involve performing or verifying risk assessments and ensuring adequate mitigation. Additionally, you will review and approve revised documents such as SOPs, BMR/BPR, and validation protocols/reports. It will be your duty to ensure validation/qualification requirements are identified and completed, verify training, implementation readiness, and completeness of supporting data, and approve and close change controls within defined QMS timelines. Your main focus will be on ensuring compliance with cGMP, data integrity, and regulatory guidelines. Key Responsibilities: - Review and approve change control requests - Assess GMP, regulatory, and quality impact - Perform/verify risk assessments and ensure mitigation - Review and approve revised documents - Ensure validation/qualification requirements are completed - Verify training, implementation readiness, and data completeness - Approve and close change controls within QMS timelines - Ensure compliance with cGMP, data integrity, and regulatory guidelines Qualifications Required: - M - Pharmacy - B - Pharmacy Additional Details about the Company: 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. The Human Resources team at Amneal partners with all aspects of the organization to drive success through effective and innovative management of people for current and future business needs. The team plays key roles such as specialists in all aspects of people management, ensuring compliance with legal requirements and best practices, providing expert advice on workforce management, and ensuring the organization is equipped to deal with developments impacting employment matters.,