knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc. Advanced verbal and written...
into functional LIMS specifications. Oversee system configuration, testing (IQ/OQ/PQ), data migration, and user training. Ensure...
within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation Other duties as assigned MPI does...
cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.) Provide guidance during protocol...
implementation/validation (IQ, OQ, PQ) Confer with management, engineering, and other staff regarding manufacturing capabilities...
controls Update documentation and data within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation...
writing skills preferred. Exposure to IQ/OQ/PQ processes preferred. Organizational skills and ability to manage multiple tasks...
are required. Experience using Maximo is required. Technical writing skills preferred. Exposure to IQ/OQ/PQ preferred. Good...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
justification for capital projects New equipment implementation/validation (IQ, OQ, PQ) Confer with management, engineering...