Sr. Spclst, Quality Assurance

Merck & Co., Inc., Rahway, NJ, USA

Rahway, NJ, USA
Quality risk management
Gmp requirements
Deviation investigations
The Senior Quality Specialist provides input into achieving the Quality deliverables and ensures that the site meets all Manufacturer’s License requirements for clinical and commercial production and is audit ready for both customers and agency inspections

Job Summary

  • The Senior Quality Specialist provides input into achieving the Quality deliverables and ensures that the site meets all Manufacturer’s License requirements for clinical and commercial production and is audit ready for both customers and agency inspections.
  • Part of a team that ensures timely and effective completion of the Quality core functions, including; Application of Quality Risk Management to all process and systems.
  • We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

Matching Summary

The Senior Quality Specialist provides input into achieving the Quality deliverables and ensures that the site meets all Manufacturer’s License requirements for clinical and commercial production and is audit ready for both customers and agency inspections.

Skills & Requirements

Must-have

  • Quality Risk Management
  • GMP requirements
  • Deviation investigations
  • Change controls
  • Internal audit program
  • Quality metrics

Nice-to-have

  • Lean / Continuous Improvement
  • Leadership
  • Project Management
  • Validation
  • Facility Qualification

Key Requirements

  • Degree or post-graduate qualification in Science, Pharmacy or equivalent
  • Eligible to act as a Qualified Person, desirable but not essential
  • Experience and knowledge of GMP Requirements for Electronic/paper free operations

Work Rights

Not specified

Tailored Resume

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