Quality Agreements and conduct supplier audits Support Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans... Validation (IQ/OQ/PQ) Experience working with PLM systems and quality documentation tools...
(Production Preparation Process), Total Productive Maintenance, Jidoka, PQ/PR, Takt Cycle, Standard Work, Value Stream Maps...
, purification, and lyophilization. Drive facility readiness through equipment qualification (IQ/OQ/PQ), process validation...
, and compliant documentation in accordance with cGMP requirements. Assist with equipment commissioning, qualification (IQ/OQ/PQ...
Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ..., including URS, IQ, OQ, PQ, Risk Assessments, and Validation Reports. Experience working collaboratively with Quality Assurance...
Preparation Process), Total Productive Maintenance, Jidoka, PQ/PR, Takt Cycle, Standard Work, Value Stream Maps, Kaizen, 4D/8D/A3...
/PQ), operational readiness, and execution of initial GMP manufacturing campaigns. Help establish scalable project...
temperature mapping and requalification of controlled temperature units. Execute IQ/OQ/PQ, requalification, and periodic review...
Design and execute DOEs to characterize and optimize new processes Develop and author pFMEAs, validation protocols (IQ/OQ/PQ...
/PQ or equivalent) for: o Process changes o Mold repairs or modifications o Equipment changes or refurbishments... o Material changes impacting existing validated products Execute and support IQ/OQ/PQ for new or modified molds, processes...