& Compliance (GxP / CSA) Support IT validation lifecycle activities (URS, IQ/OQ/PQ, RTM, validation reports) Ensure...
documentation is robust enough, identify gaps between OQ and PQ, and determine whether current qualifications can support.... Strong understanding of IOQ/OQ/PQ expectations. Ability to perform gap assessments. Tank qualification experience. Mixing...
management. Execute functional and validation test cases across SIT, UAT, and PQ phases for regulatory (GPS, PRISM, CREDO... across SIT, UAT, and PQ phases for regulatory (GPS, PRISM, CREDO), clinical (GCSDW, Veeva Vault Clinical, Eclipse), quality...
engineering drawings, including GD&T. Understanding of process validation methodologies including IQ, OQ, and PQ. Working...
in the FISI facility. Support the execution of qualification/validation protocols (IQ/OQ/PQ/PV/CV/CSV), including the...
experience - evaluation, purchase, qualification (IQ/OQ/PQ), service contracts, and decommissioning Experience with regulated...
., URS, FRS, IQ/OQ/PQ, validation summaries). Assess impact of system changes and support change control activities related...
& Commissioning When needed, assist with installation, commissioning, and qualification (IQ/OQ/PQ) of new equipment and systems...
of delivery. Qualify manufacturing equipment to ensure the fulfillment of all requirements including IQ/OQ/PQ validation...
successful yield improvement and process optimization projects. Experience leading CAPA and process validation (IQ/OQ/PQ) projects...