AIQ (Analytical Instrument Qualification)

Skaneateles, NY - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

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:

Bachelors/masters 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).

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 perio...