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Online Resumes with "Deviation Management"

Clinical Quality Assurance - 15 Years of Experience - Near 27502

Tags for this Online Resume: Root Cause Analysis, ISO, Corrective Actions, Management, Policies and Procedures, Process Improvement, Quality Assurance, CAPA, Quality, Manufacturing, cGMP, CFR 21, Teamwork, Auditing, Deviation Management, SPE, ASQ CQIA, Calibration/Validation, Product Release, Direct observations, Training, MS Suites, EU Regulations, CLIA

Clinical Quality Assurance

SUMMARY * 20+ years of experience in Quality Management and continuous improvement of quality, within Drug Safety, Clinical, Manufacturing, Regulatory Compliance and R &D domains of Bio-Pharmaceuticals * Conducted risk based Investigator site global audits including contract global central clinical labs * Conducted and Managed CRO's, 3rd party vendors / service providers for GCP and GvP compliance * Supported Internal and e...

Tags for this Online Resume: Services, Compliance, Infrastructure, Link Access Procedure (LAP), Research and Development, SDLC, Test, Packaging, Product Development, Quality

Featured Profile

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

Biological Technician

Tags for this Online Resume: Microbiology, Accounts Payable, Accounts Payable/Receivable, Chemistry, Hematology, Immunology, Management, Oncology, PEDIATRIC, Public Health