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Online Resumes with "ICH Q7"
Director of Quality, Food Safety and Regulatory Affairs
Contribution over 20 years of experience ensuring continuous improvements to deliver manufacturing and quality efficiency, I am writing in response to a Food Safety & Quality Management System and Regulations Affairs opportunity. Able to define, analyze, and improve complex applications, established effective food safety, quality regulatory, sanitation, and operational programs. I bring extensive knowledge, experience, pro...
Tags for this Online Resume: Quality Management Systems, Food Safety Fundamental Specialist, Certified Quality Management, Certified Quality Engineer, SQF Specialist, Lean Manufacturing & Continuous Improvement
Process/Chemical Engineer
Iām looking for opportunities where I can mix the hands-on work with process troubleshooting/optimization in combination of managing of a product/project from the decision-making level regarding capital projects, project direction, etc. I have worked on all facets in the lifecycle of a process/product from the R&D side in its development and optimization coming into a fully validated manufacturing process and then supporti...
Tags for this Online Resume: Chemical, Pharmaceutical, Process, Engineer, Manufacturing, Plant, Optimization
Quality Assurance Associate Managert
Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...
Tags for this Online Resume: Quality Assurance, FDA regulations, CAPA, Document Control, Change control
Quality Engineer - 14 Years of Experience - Near 91016
ļ Over14 years of in-depth experience in the pharmaceutical industry. ļ Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. ļ Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
Biologist - 5 Years of Experience - Near 60608
Summary * 10 years research experience, broad scientific knowledge with solid publications. Lead projects from initiation, planning, design, and execution to publication * Daily responsibility in optimizing conditions, developing protocols and training graduate students * Strong R programming skill, familiar with statistical inference and regression modeling * Familiar with bowtie2, tophat, cufflink, samtools and rMats for ...
Tags for this Online Resume: C Programming Language, Cancer, Data Analysis, Data Processing, ELISA, EMT, Extensible Markup Language (XML), Genotyping
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Quality Coordinator - 5 Years of Experience - Near 08817
PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...
Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
