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Validation Expert

3 weeks ago

Jersey City, New Jersey, United States Kasmo Global Full time

We are seeking an experienced Validation Expert to drive quality and compliance initiatives at Kasmo Global. As a key member of our team, you will be responsible for ensuring our products meet regulatory requirements.

Key Responsibilities
  1. Develop Engineering Specifications: Create and maintain accurate URS, FRS, DS, and other engineering specifications that meet regulatory needs.
  2. Validate Products: Execute IQ, OQ, PQ, PV, CSV, and MVP processes to guarantee product safety and efficacy.
  3. Implement Quality Systems: Establish and maintain change control, non-conformance, and requalification protocols to ensure compliance with GMP, FDA, and other regulatory standards.
  4. Stay Compliant: Maintain expertise in cGxP principles, ISO 13485, ISO 14971, and 21 CFR 820 regulations to ensure our products meet industry standards.
  5. Lead CQV Efforts: Collaborate with cross-functional teams to lead CQV efforts for new and existing systems, resolve issues, and create detailed validation documentation.