Amneal Pharmaceuticals

Assistant Manager, QMS | Change Control

Amneal Pharmaceuticals  •  Ahmedabad, IN (Onsite)  •  5 months ago
Expired
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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.

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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