Manager, Contract Manufacturing
with GMP regulations. Process Validation: Develop and execute validation protocols (IQ, OQ, PQ) for oral solid tableting...
with GMP regulations. Process Validation: Develop and execute validation protocols (IQ, OQ, PQ) for oral solid tableting...
regulations. Process Validation: Develop and execute validation protocols (IQ, OQ, PQ) for spray drying and other drug product...
, fixtures, test equipment, and electromechanical assemblies. Lead validation activities, including IQ/OQ/PQ, test method..., test protocols) Experience with IQ/OQ/PQ and process validation. Comfortable working directly with assemblers, suppliers...
activities. Participate in equipment and process qualification (IQ/OQ/PQ MPI does not discriminate on the basis of race...
-on experience and analytical problem-solving skills Proven Project Management skills and experience Experience using IQ/ OQ/ PQ...
Performs engineering design of test equipment, assembly equipment, fixtures, and tools;Performs IQ/OQ/PQ validation activities...
), and Performance Qualification (PQ). Develop Statistical Process Control (SPC) charts and Out of Control Action Plans (OCAP..., and Capability & Normality Assessments, and IQ/OQ/PQ;SPC charts and OCAP;Pre-market product development, including Product...
timelines;Ensure adequate process development and validation (IQ/OQ/PQ) occurs for suppliers’ manufacturing processes Define...
, DQ, IQ, OQ, PQ protocols as well as summary reports. Lead and document troubleshooting efforts of issues encountered...
, DQ, IQ, OQ, PQ protocols as well as summary reports. Lead and document troubleshooting efforts of issues encountered...