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Online Resumes with "GMP Regulation"
Validation Consultant-18 years experience in cGMP regulated environment-Dallas, Georgia
Technically accomplished, results oriented professional with 17 years CFR Part 11and GAMP 5, Part 58, Parts 210 & 211, Part 600, 601,610, Part 1270, 1271and Part 820 cGMP regulated environment with 10 years working experience writing, developing and executing validation protocols, managing calibration programs, maintaining and upgrading automated systems in a cGMP environment. Creative Metrologist/Chemist/Biologist and (IQ,...
Process Scientist - Southeastern PA - 25 years cGMP experience - 13+ years in Biopharm
To secure a position in a cGMP regulated Pharmaceutical or Biopharmaceutical environment in which my years of relevant experience can be utilized. Positions related to "Process Scientist", "Scientist", "Engineering", "Process Equipment/Instrument/Biopharm Sales" ALSO to be considered.
Tags for this Online Resume: Aseptic technique, Technical support, GMP, monoclonal antibody, Project, Process
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Department Manager - 20 Years of Experience - Near 45249
Challenging permanent commitment as Manager or Director in Facilities Management and Engineering, Operations, Maintenance Engineering Management, Facilities Electrical Engineering, Startup Ventures/Critical Systems and Continuous Improvement Teams with Visionary Cost Effective Team PM Approach. Available for international assignments and resource planning and implementation. Reliability and asset management catalyst for all...
Ideal Companies: Pfizer
Tags for this Online Resume: Facilities, Electrical Engineer, Organizational Manager, Technical Capabilities Manager, Facilities Manager, Utilities Manager
Production Supervisor - 18 Years of Experience - Near 90041
Summary Qualified manufacturing supervisor with 10 years production experience, professionally skilled in leading high productive team, using lean manufacturing principles to reduce cost and increase process efficiency. In-depth knowledge of cGMP regulation and FDA compliance. Dedicated leader with demonstrated ability to train, manage and motivate team members to achieve organization goals and objective. Accomplishments Pl...
Ideal Companies: A growing or prominent biopharmacuetical company. Gilead, Amgen, Roche, Kite, Novartis
Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Control, Inventory, Manufacturing, Corrective Actions, Lean Manufacturing, Production Planing, ISO 8 environment, Chaired Daily QIT meetings
Electromechanical Equipment Assembler - 1 Years of Experience
SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.
Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control
Technical Writer - 20 Years of Experience - Near 92880
QUALIFICATIONS * Certified Technical Writer with more than 10 years of experience leading and managing technical writing projects and document management functions in the manufacturing industry * Able to manage multiple projects simultaneously while complying with all GMP regulations * Extensive SAP experience * Worked closely with Engineering to implement redlines in a timely manner * Expert in MS Word/Office * Updated and...
Tags for this Online Resume: SAP, R&D, Technical Writing, Engineering, Documentation, SPC, Status Report, Test, Training, Version Control
Production Supervisor - 19 Years of Experience - Near 29732
Summary Manufacturing and production professional skilled in leading high-producing teams and using lean manufacturing to Reduce costs and increase process efficiency. Qualified Production Supervisor with 18 years of manufacturing including cross-training and scheduling employees ordering parts record-keeping and Meeting all production deadlines. Versatile and experienced in production supervision and quality assurance. In-...
Tags for this Online Resume: Corrective Actions, Customer Service, Lean Manufacturing, Manufacturing, Quality, Quality Assurance, Quality Control, 5S, Assembly Line, Management
Production Supervisor
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems
Supply Chain Manager - 18 Years of Experience - Near 02370
PROFESSIONAL SUMMARY A logistics professional with expertise in all aspects of Distribution Operations. Strengths include implementation of warehouse management systems (WMS), compliance with all ISO, OSHA, FDA and GMP regulations, project management, implementation of ERP system (SAP R/3), site selection and warehouse consolidations and inventory control. Technical experience with Pick/Pack systems, Bar Coding and Scanning...
Tags for this Online Resume: Inventory, Inventory Control, Consolidations, Legacy, Management, Order Processing, SAP, SAP R/3, Site Selections, Warehouse Management
Industrial Engineer - 3 Years of Experience - Near 10453
Profile Industrial Engineer with strong experience advanced product quality planning (AQPP). Experience in validation protocols (IQ/OQ/PQ/CSV), data analysis, quality and process reports, regulatory compliance from defect detection & rejection and documentation. Detail-oriented professional with lean six sigma, 5-s, value stream mapping, scheduling, process improvement, and continuous improvement efforts, layouts, data anal...
Tags for this Online Resume: Manufacturing, Quality, Quality Assurance, Medical, Collection, Complaints, Compliance, Corrective Actions, Data Analysis, Documentation
