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).

Job Tags

Similar Jobs