Assistant Manager, QMS | Change Control

Job Description

Job 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 : Advanced

cGMP, GDP & ICH Q10 knowledge : Advanced

Global regulatory compliance knowledge : Advanced

Automated QMS platform proficiency : Advanced

Data integrity (ALCOA+) knowledge : Advanced

Qualifications

M - Pharmacy

B- Pharmacy

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.