QA Consultant Utilities

Our client, a leading pharmaceutical manufacturer, is seeking a consultant to support their technical department with quality assurance documentation for critical utility systems. This role bridges the gap between technical operations and compliance by managing deviations, change controls, and root cause investigations.

• Own and manage the backlog of utility-related deviations and CAPA plans within established timelines.
• Lead root cause analysis (RCA) sessions for recurring deviations involving HVAC, purified water, and environmental monitoring systems.
• Author high-level quality documentation and deviation reports compliant with EU GMP Part I standards.
• Support OOT/OOS trend analysis, risk stratification, and data integrity reviews for utility systems.
• Provide technical oversight and serve as a backup for utility operations, including BMS alarm management and system monitoring.
• Strengthen the link between preventive maintenance activities and deviation root causes to improve system reliability.

• You have a Bachelor or Master in Electromechanical, Mechanical, or Building Services Engineering.
• You bring 3+ years of technical engineering experience within a GMP-regulated manufacturing environment.
• You possess expertise in quality assurance processes including CAPA, deviation management, and root cause analysis (RCA).
• You have hands-on technical knowledge of utility systems such as Purified Water (PW), HVAC/AHU, and BMS/EMS.
• You're familiar with Commissioning, Qualification, and Validation (CQV) processes and EU GMP regulations.
• You're comfortable with a documentation-heavy role and possess strong analytical troubleshooting skills.

Nice to Haves

• Experience with FDA regulations and 21 CFR Part 11 data integrity standards.
• Knowledge of validation engineering or maintenance management systems like SAP PM.
• Prior experience in a lead or supervisory capacity within a technical or pharmaceutical environment.

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