monthly loan reports and review loan approvals for soundness of decisions. Update Loans PQ as needed in Beta, Demo and Live...
, including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work...
into manufacturing laboratory Troubleshoot existing processes and provide guidance on potential enhancements Perform IQ, OQ, and PQ...
sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met. Serve as the... that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA approvals...
validation (IQ/ OQ/PQ) protocols and reports. Create/update Standard Operating Procedures & Manufacturing Work Instructions...
, SAT, IQ, OQ, PQ, or other validation/qualification methodologies Experience with CMMS, ERP, or engineering documentation...
such as bioburden, BET, and dose audit testing. Support validation (IQ, OQ, and PQ) development and execution internally...
packaging systems) Lead and support equipment qualification activities (IQ/OQ/PQ) and ensure adherence to validation standards... management experience Experience with equipment qualification (IQ/OQ/PQ) Familiarity with Lean Six Sigma tools...
engineering Experience supporting manufacturing transfer activities for medical products, including: IQ/OQ/PQ validation...
efforts. Generates validation documentation as required (URS, FRS, DRS, FAT, DQ, engineering studies, IOQ, PQ, PV... validation, spreadsheets, test method validation and process validation. Writes and/or revises IQ, OQ, PQ related documents...