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Amgen Technology Private Limited

Deputy Manager-Quality Assurance

5-10 Years

This job is no longer accepting applications

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  • Posted 5 months ago

Job Description

As the Deputy Manager, you'll be responsible for:

  • Performing vendor audits to ensure compliance with applicable regulatory guidelines and Standard Operating Procedures.
  • Liaising with staff at our manufacturing unit, Jubilant Generics Ltd., to ensure quality plans, goals, and initiatives are understood and implemented.

Challenges: You'll be responsible for consistently upgrading and maintaining procedures aligned with regulatory standards and ensuring regulatory compliance levels.

Scope of Work

QA Authentication:

  • Verifying protocol and procedural requirements.
  • Conducting internal and external audits.
  • Providing technical and regulatory input in the development and application of procedures, training materials, communications, and/or tools.

Documentation:

  • Initiating procedural changes as needed.
  • Preparing audit reports.
  • Evaluating regulatory updates received and sharing them with the manufacturing unit for their evaluation and impact assessment.
  • Assisting senior management in preparing various trends and their evaluation.

Internal Audits/Vendor Audits:

  • Maintaining system and procedural compliance through Internal System/Facility audits/spot audits.
  • Conducting vendor audits for key services to ensure uniform quality and assurance.

About Company

Horizon Therapeutics focuses on developing innovative medicines for rare and rheumatic diseases, dedicated to improving patient lives.

Job ID: 119723075