AIQ (Analytical Instrument Qualification) SME
- Serve as the technical SME for qualification of analytical equipment in manufacturing setup.
- Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 requirements.
- Lead and support equipment lifecycle activities, including requalification, decommissioning, and periodic review.
- Ensure data integrity compliance in computerized systems interfaced with analytical instruments.
- Collaborate with Quality, Validation, Metrology, IT, and Lab teams to define qualification strategies for new and upgraded equipment.
- Maintain traceability between user requirements, functional specifications, and qualification deliverables.
- Provide guidance on change control and impact assessments for equipment modifications or upgrades.
- Support audits and inspections by presenting qualification documentation and providing SME-level responses.
- Drive continuous improvement in qualification practices and documentation templates across global sites.
- Bachelor's or master's degree in chemistry, Engineering, Life Sciences, or a related technical field.
- Experience in analytical equipment qualification, preferably in a GMP-regulated medical device or pharmaceutical environment.
- In-depth understanding of.
- FDA regulations (21 CFR Parts 820, 210/211, 11).
- GAMP 5 and ISO 13485.
- Data integrity principles (ALCOA+).
- Experience qualifying and maintaining Manufacturing equipment.
- Familiarity with electronic document systems, validation tools, and computerized system validation.
- Certification in Lean Six Sigma, ASQ, or ISPE.
- Experience supporting global harmonization of validation practices across multi-site environments.
- Working knowledge of medical device testing requirements, especially for infusion devices, sensors, or diagnostic platforms.
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