QA Specialist Equipment and Facilities Qualification

Job Description:

Responsibilities

• Commissioning & Qualification Lifecycle: Review and approve reports, protocols, and test documentation for commissioning and qualification of facilities, utilities, computerized systems, equipment, and laboratories in line with Lonza standards and regulatory expectations.
• GMP Design Review: Support the review of GMP design deliverables (flows, zoning, layouts) to ensure compliance.
• Deviation Management: Ensure discrepancies or deviations related to facilities and utilities are assessed, documented, traceable, and resolved.
• Periodic Requalification & Validation Maintenance: Review and approve periodic requalification documentation (e.g., freezers, autoclaves, HVAC, biosafety cabinets, cold rooms). Confirm validated state through validation maintenance reports. Review and approve decommissioning documentation as applicable.
• Quality & Risk Management: Review and support management of quality records (deviations, CAPA, change controls, investigations, product quality review). Maintain high standards of GMP compliance, documentation quality, and technical accuracy.
• Audit Readiness: Promote and maintain a state of audit readiness across qualification activities.
• Timely Delivery: Ensure assigned work is delivered within agreed timelines, proactively identifying and escalating risks or delays.
• Continuous Improvement: Contribute to process improvement initiatives and support implementation of new tools or approaches.
• Other Duties: Perform additional quality and compliance tasks as assigned.
• Education & Experience

• Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, or related scientific field.
• Minimum 5 years of relevant experience in regulated pharmaceutical industry (engineering, manufacturing, QA, QC).
• Experience in commissioning, qualification, and validation of manufacturing equipment, facilities, utilities, support systems, laboratory equipment, and computerized systems.
• Experience in process or cleaning validation beneficial.
• Proven experience in EMA/FDA regulated environments with strong knowledge of ICH, PIC/S, EU, and US regulatory requirements.
• Experience in chemical and biological GMP API manufacturing with ability to interpret and implement quality and regulatory requirements.
• Knowledge of CQV approaches and electronic validation tools (e.g., Kneat Gx).