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Amneal Pharmaceuticals
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Assistant Manager, QMS | Change Control

Assistant Manager, QMS | Change Control

Amneal Pharmaceuticals

9 - 12 years

|

30 - 35 Lacs

Posted:2 weeks ago| Platform:

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Skills Required

training analytical qms regulatory compliance data integrity gmp process equipment ich

Work Mode

Work from Office

Job Type

Full Time

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

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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