activities and processes. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities...
regulations within the E.U. and U.S. FDA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...
design Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability...
scripts, traceability matrices, and validation reports Execute IQ/OQ/PQ testing, risk assessments, data integrity (ALCOA... validation activities including IQ/OQ/PQ, requirements development, test execution, and traceability Familiarity...
validation, and compatibility assessments. Conduct and support equipment and process qualification activities (IQ/OQ/PQ...
, vendor selection, FAT/SAT execution, IQ/OQ/PQ, and production release. Troubleshoot mechanical, electrical, pneumatic.... Prior exposure to regulated environments (FDA and ISO 13485) and equipment qualification (IQ/OQ/PQ) is a plus. Knowledge...
knowledge of loan products and associated system(s) (Loans PQ – loans decisioning system) Proven ability to garner business...
manufacturing continuous improvement and development as the Quality team member for validation including IQ, OQ, PQ, and test method...
knowledge of loan products and associated system(s) (Loans PQ – loans decisioning system) Proven ability to garner business...
, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...