Assistant Manager, QMS | Change Control

0 years

3 - 5 Lacs

Posted:3 weeks ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Part Time

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

M - Pharmacy

B- Pharmacy


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.

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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