Job Description
What you’ll do:
- Review and approve the Validation Master Plan (VMP), process validation protocols (including Process Performance Qualification and supporting studies), ensuring alignment with cGMP requirements, applicable regulatory standards, Lonza policies and procedures, and customer expectations.
- Provide QA oversight during validation execution to ensure strict adherence to approved protocols and standard operating procedures (SOPs).
- Review and approve discrepancies and deviations arising during validation activities; ensure thorough investigation, robust root cause analysis, and appropriate assessment of impact on validation status.
- Oversee approval and timely closure of associated Corrective and Preventive Actions (CAPAs).
- Review and approve validation reports, confirming that all acceptance criteria are met, deviations are adequately resolved or justified, and conclusions are data‑driven and fully compliant with regulatory expec...
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