AIQ (Analytical Instrument Qualification) Job at cGxPServe, Skaneateles, NY

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  • cGxPServe
  • Skaneateles, NY

Job Description

Job Description:
Serve as the SME for qualification of analytical equipment in a GMP manufacturing setup, ensuring compliance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.

Responsibilities:
  • Author/execute URS, DQ, IQ, OQ, PQ protocols.
  • Oversee equipment lifecycle: requalification, decommissioning, periodic reviews.
  • Ensure data integrity in computerized systems.
  • Collaborate with Quality, Validation, Metrology, IT, and Lab teams.
  • Maintain traceability between requirements and qualification deliverables.
  • Support audits and provide SME responses.
  • Drive continuous improvement in qualification practices.
Requirements:
  • Bachelor's/master's in chemistry, Engineering, Life Sciences, or related field.
  • Experience in analytical equipment qualification in GMP medical device or pharma environment.
  • Knowledge of FDA 21 CFR Parts 820, 210/211, 11; GAMP 5; ISO 13485; ALCOA+.
  • Familiar with manufacturing equipment, validation tools, and computerized system validation.
  • Lean Six Sigma, ASQ, or ISPE certification.
  • Global multi-site validation experience.
  • Knowledge of medical device testing (infusion devices, sensors, diagnostics).

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