AIQ (Analytical Instrument Qualification)

Key Responsibilities:

• 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.

Qualifications:

• 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.

Preferred Qualifications:

• 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.