Assistant Manager - QMS / Change Control

Roles & Responsibilities:
• Review and approve change control requests from cross-functional teams
• Assess GMP, regulatory, and quality impact on process, equipment, documents, and systems
• Perform and verify risk assessments with proper mitigation plans
• Review and approve revised SOPs, BMR/BPR, validation protocols, and reports
• Ensure validation and qualification requirements are identified and completed
• Verify training effectiveness, implementation readiness, and supporting documentation
• Approve and close change controls within defined QMS timelines
• Ensure compliance with cGMP, data integrity (ALCOA+), and global regulatory guidelines

Qualification:
• Master of Pharmacy (M.Pharm) / Bachelor of Pharmacy (B.Pharm)

Experience:
• Experience in Quality Assurance / Change Control within pharmaceutical manufacturing

Skills:
• Advanced analytical and problem-solving skills
• Strong knowledge of cGMP, GDP & ICH Q10
• Global regulatory compliance expertise
• Proficiency in automated QMS platforms
• Strong understanding of Data Integrity (ALCOA+) principles

About the Organization:
Amneal Pharmaceuticals is a leading global pharmaceutical company engaged in developing and manufacturing high-quality generic and specialty medicines. The organization promotes diversity, inclusion, and equal opportunity while maintaining strong regulatory and quality compliance standards worldwide.