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Online Resumes with "validation protocols"
Mechanical Engineer - 15+ Years of Experience - Near 27587
PROFESSIONAL SUMMARY A Mechanical Engineer and Engineering Manager with over 15 years' experience designing & directing engineering development and project management. An innovative problem solver with thorough understanding of risk factors, root cause analysis, cost reduction, process improvement, department resources and project budgeting. Proven ability to minimize department and equipment expenses, maximize equipment co...
Tags for this Online Resume: Documentation, ISO, ISO 9001, Management, Manufacturing, Design Documents, Engineering, Medical, Medical Devices, Risk Assessment, Automation
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology
Quality Assurance Director - 0 Years of Experience
Engineering professional with in depth work experience in lean manufacturing, process engineering, research and development, quality assurance, Quality System programs including CAPA, Audits, Supplier Quality, RiskManagement, Complaint Investigations and Document Control. * Experience in root cause analysis, developed testing strategies to support test executions, process verification/ validation, Assembly line, Current/new...
Tags for this Online Resume: Manufacturing, Product Development, Reliability, Root Cause Analysis, Statistical Analysis, Assessments, Compliance, Documentation, Engineering, Evaluate
