AIQ (Analytical Instrument Qualification)
AIQ (Analytical Instrument Qualification)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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.
- 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).
Employment Type
Full-time
