qualifications (10), operational qualifications (OQ), and performance qualifications (PQ) Ensure that all documentation is completed... in planning Process Validation, IQ/OQ/PQ/MSA (software qualification a plus). Knowledge of Statistical Analysis of data...
Program at PML’s facilities. Lead and support commissioning, qualification, and validation (IQ/OQ/PQ) activities...
to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular...
as a subject matter expert (SME) Process Quality Develop, review, and approve validation protocols (IQ/OQ/PQ), test methods...
design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects... activities (IQ/OQ/PQ). Support internal and external inspections and investigations (including Quality and HSE). Maintain...
. Job Responsibilities: Complete project/part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ...
/OQ/PQ) Experience with aseptic processing, HVAC systems, or utilities Familiarity with ISO standards and FDA audits...
that involve: Process Mapping, Manufacturing Process Instructions, DOE and Process Instructions, OQ/PQ Protocols and Reports, IQ...
. Experience leading CAPA and process validation (IQ/OQ/PQ) projects Experience in owning the introduction of new products...
& Qualification Support Partner with Quality and Validation teams to support IQ/OQ/PQ for solid dose equipment and supporting... regulatory standards. Experience supporting process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ...