QA Specialist Equipment and Facilities Qualification

As a QA Qualification Specialist, you will be responsible for supporting, reviewing, and approving qualification documentation for facilities, utilities, computerized systems, and equipment in accordance with GMP requirements, Lonza standards, and governance. You will collaborate with site quality teams to enable operational performance, ensure technical consistency, and deliver compliant documentation. This role also provides oversight into validation and technical service activities, including process and cleaning procedures, ensuring audit readiness and regulatory compliance.

Key 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 revi...