Manufacturing Compliance

Role & responsibilities

• Lifecycle Qualification & Validation: URS, risk assessment (FMEA), DQ, IQ, OQ, PQ for AHU/HVAC, PSG, PW/WFI, and compressed air systems.
• AHU/HVAC: Perform airflow visualization, air changes, pressure differentials, temperature & RH mapping, HEPA integrity testing, and cleanroom classification.
• Pure Steam Generator: Qualify PSG generation, distribution, and condensate quality; verify non-condensable gases, superheat, and steam dryness.
• Water Systems: Validate TOC, Conductivity, Microbial counts, Endotoxin for PW/WFI per point-of-use and routine sampling plans.
• Compressed Air/Gas: Validate dew point, oil aerosol, particulate, microbial parameters and ensure point-of-use filtration integrity.
• Documentation & Data Integrity: Preparation and review of URS, Protocols, SOPs, Reports and Risk Assessments and ensure ALCOA+ compliance.
• Cross-Functional Collaboration & Audit Support: Interface with Engineering, Production, QA QC, and Vendors.
• Training & Continuous Improvement: Train teams on validation protocols and SOPs.
• Assess impact of changes, plan requalification, and maintain equipment qualification status.
• Investigate deviations, perform RCA, and implement effective CAPA.
• Prepare and present validation documentation during regulatory and customer audits.
• Prepare and review SOPs and operate equipment used for qualification and validation activities.

Preferred candidate profile

Sr. Executive Equipment Qualification & Validation (Engineering interface)