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Online Resumes with "validation protocols"
Chemist - 20 Years of Experience - Near 33411
I am a Quality Assurance professional with over thirty years of experience in Quality Assurance in the Pharmaceutical, Biotechnology and Medical Device Industry.
Ideal Companies: Medical Device or Pharmaceutical Companies
Tags for this Online Resume: Failure Investigation, Corrective Action, Preventive Action, Training, cGMP's, Florida, Auditing, pharmaceutical
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,...
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
QA ASSOCIATE - 3 Years of Experience - 08873
• Ensure implementation of cGMP, GLP and GDP • Monitoring processing and laboratory activities in the facility on a daily basis • Hosting regulatory audits • Member of internal audit team • Preparation and implementation of Standard Operating Procedures, Stability Protocols, Master Batch Production Records, etc. • Evaluation and Qualification of vendors for raw materials, packaging materials and contract services • Samplin...
Tags for this Online Resume: QUALITY ASSURANCE, QA TECNICIAN, VALIDATION, DOCUMENTATION, QA AUDITOR, BMR, Test, Audit, Documentation, Internal audit, Manufacturing, Microsoft, Microsoft Office, Packaging
Senior Process Validation Lead
Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.
Clinical Research
PROFILE * 10 years of progressive leadership experience implementing and validating protocol specific clinical research databases. * Commended performance as a trainer and mentor, creating training programs for new hires and developing learning aids to harmonize several internal departments * Effective team management skills including conflict resolution, delegation and change management.
Tags for this Online Resume: Documentation, Support, Technical Support, Training, Project Management, Project Manager, Protocol, Leadership, Change Management, Clinical Research
Production Manager
Additional Qualifications * Experienced with the following software and systems: MS Office, SAP, Trackwise, Minitab, etc. * Experienced in technical writings such as Work Instructions, SOP's, PPM's, Capital Expenditure Requests, Preventive Maintenance Techniques, Single Point Lessons, Validation Protocols, Demand Flow Technology, etc. Experienced with the following regulations and standards: FDA, GMP, HACCP, ISO 9001, ISO 1...
Tags for this Online Resume: Consulting, Scheduling, 5S, Business Management, Facilitator, Inventory, Management, Process Improvements, Diagnostics, Operational Excellence
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Chemical Engineer - 14 Years of Experience - Near 77004
SUMMARY Over 7 years of diversified international experience in the Engineering sector including pharmaceuticals, oil and gas and power plants. Well-qualified to contribute in Pharmaceutical environment from Lab, Pilot Plant to FDA-compliant production. Experienced in both batch and continuous processes. Experienced in execution of validation processes, Temperature Mapping & knowledge in validation testing (IQ, OQ, PQ, RQ, ...
Tags for this Online Resume: IDS, Engineering, Evaluate, Manufacturing, Quality, sheets, Audit, Autocad, Autodesk AutoCAD, Automation
Life Scientist - 8 Years of Experience - Near 27617
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
Microbiologist - 6 Years of Experience
Qualifications of equipment's. * Analyst qualifications. * On the Job training. * Testing method validation. MAJOR AUDITS FACED: USFDA, TGA, MHRA, ANVISA (Brazil), UKRAINE, GSK, NHL, W.H.O, DRUG CONTROLLER AUDIT. VALIDATION EXPOSURE: * Media fill validation * Antibiotic bio assay * Excel sheet validation for calculations. * Sterility method validation * Bioburden method validation * Microbial Enumeration Test * Bacterial En...
Tags for this Online Resume: Microbiology, Quality, Quality Assurance, Quality Control, Distribution, Test, Training, Audit, Communication Skills, English Language
Quality Assurance Specialist - 15 Years of Experience
AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV)/Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance. * Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation proto...
Tags for this Online Resume: Compliance, Test, Test Cases, Automation, Documentation, Protocol, Risk Assessment, Business Requirements, SAS, Test Plan
