and experience with risk assessment, risk mitigation techniques and process validation methods and documentation (IQ/OQ/PQ, Gage R&R)...
, testing, equipment validations (IQ/OQ/PQ), and maintenance activities in compliance with GMP, FDA, and ISO 13485 requirements...
improvement opportunities. Support Design Verification (DV), Design Validation (PV), Process Validation (IQ/OQ/PQ), and product...
packaging and manufacturing validations, including: IQ / OQ / PQ. Package integrity testing (seal strength, bubble leak, dye...
, validation testing, scripted and limited-scripted test execution, OQ/PQ support, requirement analysis, defect tracking, evidence... testing, scripted and limited-scripted test execution, and OQ/PQ support Experience with requirement analysis, defect...
/PQ), and first article inspections (FAI) as part of supplier readiness. Lead structured problem-solving efforts...
and equipment qualifications, including: Process and equipment user requirement Equipment qualification (IQ/ OQ/PQ) Process...
(one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular and accurate cycle counting . Support...
and reports for equipment, utilities, facilities. (e.g., IQ, OQ, PQ). Develop and execute CQV deliverables for Sterilization... in autoclave validation and familiarity with FDA and cGMP standards. Proven experience with IQ, OQ, PQ. Strong understanding...
and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic...