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Online Resumes with "clinical trial materials"
Quality Assurance Associate
Quality Bio-Pharmaceutical professional with ISO/GMP/TQM experience and strong data management in inventory control & distribution. Ability to design, develop and improve process systems. Bi-lingual in Spanish and English. Additional skills and knowledge include: Package & Labeling Design; Documentation Editing; Contract Facility Audits; Statistical Analysis; Return Destruction Processing; Charting Trending; Contract Vende...
Ideal Companies: Open to all Medical device and bio pharmaceutical companies
Tags for this Online Resume: Quality Assurance, Documentation Specialist, Inspector, Audits, Calibration, GMP, ISO, CAPA, Change Control
venky
• 9 Years of basic research experience (Clinical Molecular Biology and Bio-Chemistry) • Excellent organization skills • Detail oriented • Solid knowledge of microbes and anti-infective therapy • Leader of quality assurance team ensuring adherence with state and federal regulations • Ability to work as part of a team or independently • Solid knowledge of adherence to federal and state regulations (JACHO) • Indust...
Ideal Companies: Pharmaceuticals, Biotech, contract research organisation
Clinical Supplies-Project Management -Quality Assurance
I'm a clinical supplies professional who has 33 years experience in end to end clinical supply chain project management, coaching and mentoring team members with respect to quality system compliance to process and GMP, root cause analysis, deviation investigation, CAPA lifecycle. Expertise in Visio, MS Project, Powerpoint, excel and word.
Tags for this Online Resume: Trackwise, clinical trial materials, Annex 13
Lawyer - 20 Years of Experience
Over twenty years of experience in drafting and negotiating business transactions * Three years of experience working on biomedical/ pharmaceutical contracts, licensing, intellectual property, clinical trial and material transfer agreements in the Research Administration and nonprofit field * USAID Assistance Management Certification * Risk management & insurance.
Tags for this Online Resume: Real Estate, Drafting, Management, Risk Management, Litigation, Litigation Support, Support, Insurance, Underwriting, Assessments
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