Assistant Manager, QMS

2 days ago


ahmedabad, India Amneal Full time

DescriptionJob Description Review and approve change control requests raised by cross-functional teams.Assess GMP, regulatory, and quality impact for process, equipment, documents, and systems.Perform/verify risk assessments and ensure adequate mitigation.Review and approve revised documents (SOPs, BMR/BPR, validation protocols/reports).Ensure validation/qualification requirements are identified and completed.Verify training, implementation readiness, and completeness of supporting data.Approve and close change controls within defined QMS timelines.Ensure compliance with cGMP, data integrity, and regulatory guidelines.Skills Required Analytical & problem-solving skills : AdvancedcGMP, GDP & ICH Q10 knowledge : AdvancedGlobal regulatory compliance knowledge : AdvancedAutomated QMS platform proficiency : AdvancedData integrity (ALCOA+) knowledge : AdvancedQualificationsM - Pharmacy B- Pharmacy 



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