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 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 impl

📌 QA Specialist Equipment and Facilities Qualification (Hyderabad)
🏢 Lonza
📍 Hyderabad