PSS Analytical Instrument Qualification Specialist
Core
Planning and execution of Analytical Instrument Qualification (AIQ) activities for In-Process Technology (IPT) equipment within manufacturing areas to ensure GMP compliance.
Role type
Analytical Instrument Qualification Specialist (C&Q team)
Builds
Qualified and compliant analytical instruments and systems for pharmaceutical/biotech manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing / GMP Compliance
Required skills
Analytical Instrument Qualification (AIQ), Computer Systems Validation (CSV), GMP regulatory knowledge, Validation documentation, Risk assessment, Deviation investigation, Change control assessment
Preferred skills
Subject Matter Expert (SME) experience, Audit/inspection support, Continuous improvement initiatives
Technologies
Digital validation platforms
Responsibilities
Prepare, review, and execute qualification protocols and reports; Perform Installation, Operational, and Qualification (IOQ) testing; Assess impact of equipment changes; Investigate qualification deviations; Support audits and inspections
Seniority
Mid-level, hands-on IC