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Online Resumes with "c GMP"
Biological Technician - 18 Years of Experience - Near 02421
SUMMARY Quality Control Chemistry works, Internal/External Audits and Inspection, Maintain Laboratory update with Quality Management. Technical work and knowledge of Biotech/ Pharmaceutical QC/QA system with cGMP and GLP compliance, Practice Quality Management and ICH regulations guided by ISO 9000+. Complete COA for drug product and biologics. Maintain liaison with contract manufacturing (CMO/CTL) Operation and collect bat...
Tags for this Online Resume: CFR Part 11, Inventory, ISO, ISO 9000, Troubleshooting, Audit, Change Control, Chemistry, Documentation, pharmaceutical
Quality Manager - 20 Years of Experience - Near 37064
Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...
Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions
Quality Control
SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...
Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits
Clinical Pharmacovigilance/Drug Safety
SUMMARY Over 35 years of cumulative global molecular research experience with an in-depth knowledge of genetic engineering, transformation, cell-culture and aseptic techniques. Well recognized in the areas of research and product development, project management and technical support in pharmaceutical and biotech industries. Ten years of experience working with United States Pharmacopeia (USP) as Expert Committee Ad Hoc Advi...
Tags for this Online Resume: Protocol, Management, Procurement, Research, Training
Production Tester - 10 Years of Experience - Near 07076
SUMMARY: Over eight years of experience in Analytical Chemistry. Extensive knowledge in the operation and trouble shooting of HPLC, GC, AA and UV. Tested a wide variety of finished and raw materials products for cosmetic, pharmaceutical healthcare and environmental companies to ensure compliance and regulations following SOP's or appropriate compendium method procedures. Managed multiple tasks efficiently and effectively. P...
Tags for this Online Resume: Inventory, Generate Reports, High Performance Liquid Chromatography (HPLC), Manufacturing, Audit, Compliance, ISO, SAP, Analytical Chemistry, Chemistry, manufacturing
ERP
Experienced with FDA cGMP and related regulations and guidelines with knowledge of computer validation methodologies and principles * Expert knowledge of tools and accelerators such as Solution Manager, SAP Infopak, HP ALM (Mercury System), * Expert configuration knowledge of SAP Planning and Manufacturing (PP PP-PI REM) MM Materials Management, Quality Management QM Batch Management, Classification with cross-functional kn...
Tags for this Online Resume: Business Development, Inventory, Inventory management, Management, Procurement, Acquisitions, Application Support, Computer Aided Software Engineering, Consulting, Distribution, it jobs, software, agile
Pharmaceutical Sales Representative - 19 Years of Experience - Near 01746
Summary Highly motivated, dedicated and results oriented sales and marketing professional with over eighteen years experience in Contract drug development and manufacturing, Engineered process equipment and Separations Technologies. Global thinker with strong business development experience. Dynamic self- starter with outstanding leadership and communication skills collaborating with multicultural, cross- functional teams t...
Tags for this Online Resume: Sales, Sales Engineer, Business Plan, Engineering, High Performance Liquid Chromatography (HPLC), Process Engineering, Heat Exchangers, HVAC, Mining, Pharmaceutical Industry, ACCOUNT DIRECTOR, DRUG DEVELOPMENT
Supply Chain Manager - 16 Years of Experience - Near 08844
Stability
Tags for this Online Resume: Management, Corrective Actions, Scheduling, Packaging, Pharmaceutical, Pharmaceutical Industry, Pricing, Purchasing, ISO, Procurement, Inventory Control, Planning, cGMP
Quality Specialist – two years of experience – Qualification of raw materials - Quality Assurance – Compliance – Change controls- FDA requirements – SOP’s – cGMP-familiar with CAPA
In my two years of experience at Johnson & Johnson, I have gained vast knowledge about different areas : Quality assurance,Complaince, Procurement and Analytical but my goal is to excel in the field of Compliance/Quality Assurance with high level of persistence
Tags for this Online Resume: Compliance, Quality Assurance, Change controls, Leadership, SOP, Computer
Quality Manager - 12 Years of Experience - Near 19120
I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...
Tags for this Online Resume: Documentation, Manufacturing, Integrate, Oracle, Graphical User Interface, Intranet, Microsoft Visio, Microsoft Visio Professional, Microsoft Word, Statistical Analysis, Technical Writer, Documentum, Sharepoint, Trackwise
Chemist - 20 Years of Experience - Near 02467
PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities
Chemist - 9 Years of Experience
Summary * Take a challenging, creative role to work in the field of Chemistry and implement the expertise in development and analysis of quality compounds efficacious for the organization * Experience in Quality Control of the raw materials to manufactured product * Experience with HPLC, IR, Chromatography, UV - VIS spectroscopy instruments * Familiar with Wet Chemistry Techniques including pH testing, Viscosity testing and...
Tags for this Online Resume: Chemistry, Analytical Chemistry, BIS, ISO, ISO 9001, Quality, Quality Assurance, Test, Documentation, Notebook Computer
