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Featured Profile

Life Scientist - 20 Years of Experience - Near 30523

QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all produ...

Tags for this Online Resume: Training, Project Management, Distribution, Management, Risk Management, CFR Part 11, Design Specification, pharmaceutical, protocol, Leadership, Staff development, cleaning validation, process validation, computerized systems validation, Program Management, QC testing, Chemist, CAPA, NCR, Customer Complaints, Supplier Quality, commissioning, equipment qualification, equipment purchase, Change control, Auditing, Medical Devices class I, II and III, Pharmaceutical development DOE, Pharmaceutical Clinical Scale-up, Mfg./Pkg. Management, ISO13485, Technical Reporting, FDA site QA contact