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Online Resumes with "GMP GLP GCP"

Senior Manager Capital Project Engineering

Interested in a management position within the scientific or mechanical segments of the biotech/pharma industry, utilizing my technical and development strengths, expanding my areas of expertise and increasing the scope of my responsibility within a world-class organization.

Tags for this Online Resume: Project Leadership, GMP, GLP, GCP, Budget Planning & Cost Control, Client Relations, Proposal Development, Contract Administration

Compliance Manager/Auditor

To obtain a position working as a Microbiology Business Analyst and Project Manager in a pharmaceutical/biotech validation environment, oriented toward management advancement. Over 20 years of experience in the Pharmaceutical Industry, 16+ years of those years are with GxP (GMP, GLP, GCP) systems compliance/QA and 21 CFR Part 11. Experience includes GxP system implementation projects, documentation/SOP writing/review.

Medical Device Project Manager, Indiana

Seeking a position with a start up or established company where I can apply my diverse management and quality compliance experiences and skills to further my professional and personal growth.

Tags for this Online Resume: Medical Devices , Project Management, Veterinary Technology , Communication , Biomedical Leadership & Training , Preclinical & Clinical Trials , Safety Protocols , Regulatory Compliance Process Improvement , Facility Management , Research, Quality Assurance , Regenerative Medicine, Product Development , Supply Chain Management , Vendor Relations, Strategic & Tactical Planning , ISO 13485, GMP/GLP/GCP, Administrative

Biochemist - 18 Years of Experience - Near 84037

Compliance and Quality Manager in Pharmaceutical manufacturing. Highly experienced with Aseptic, Solid Dosage, and Liquid Manufacturing including 15+ years in management. Key player in successful Regulatory relationships with Inspectors across 4 continents. Developed and implemented Quality systems, processes, procedures, and policies. People acumen across all levels from executives to entry-level.

Tags for this Online Resume: Quality, Compliance, Quality System, Standards (GMP, GLP, GCP, ICH, ISO, WHO, CE, Med Device), Training, Investigations (CAPA), Documentation, Salt Lake City

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

Featured Profile

Senior Business Systems Analyst/IT Project Manager - 7+ Years of Experience - Chicago IL

Strategic and innovative Senior Business Systems Analyst/IT Project Manager with over 7+ years� experience leading large scale IT projects. Highly accomplished and forward-thinking, with diverse expertise in IT systems and business systems analysis. Talented senior system analyst and senior business systems analyst with broad IT experience across multiple sectors. Create, design and implement efficient, consistent and strea...

Ideal Companies: Baxter, Takeda, JP Morgan Chase, Citibank, HSBC, Allstate, Bank of America, Standard Chartered, State Farm, Johnson & Johnson, Procter & Gamble

Tags for this Online Resume: Business Requirements to System Design, Laboratory/QA Systems like LIMS, Empower 3, ELN, Atlas, SDMS NuGenesis Configuration/testing, Regulatory Compliance for FDA, EU Annex 11, 21CFR Part11 Compliance, ERP SAP-QM, SDLC/Waterfall/Agile Development Methodologies, Project Management, Custom Software Development, Systems Engineering, System Risk Mitigations/Integrations, Enterprise wide implementation, ROI Analysis, Costing , UAT, System Integration Testing, Performance Testing, Regression testing, Acceptance Testing, Validation Testing Scripting and documentation. GXP, GMP, GLP, GCP, Lean Six Sigma Green Belt expertise, C, Oracle 10g/11g, SQL Server, PL/SQL Stored Procedures, Costing, Project Scheduling, Cross-Functional Supervision, Team Building, Client Relations Presentations, Business/IT Planning, Vendor Management, UML Designing, MS Project, Gantt Chart, MS Office, Rational Rose, URS, FRS, SDD, Installation, Traceability Matrix, BI, Cognos, QlikView, Infomaker Report, MS Test Manager, Sharepoint, Business Operation Excellence, Process Improvement Excellence

Quality Engineer - 19 Years of Experience - Near 77459

SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485

Clinical Regulatory Affairs - 20 Years of Experience - Near 55311

Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...

Tags for this Online Resume: Imaging, Cardiology, Integrated Development Environments, Management, Data Management, PACEMAKER, Pacemakers, Research, Clinical Research, Publications

In Between - 15 Years of Experience - Near 27572

QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Developme...

Tags for this Online Resume: Training, Corrective Actions, Data Processing, Good Manufacturing Practices, Manufacturing, Quality Assurance, Test, Data Entry, Document Management, Filing

Clinical Research Associate - 11 Years of Experience - Near 94112

SUMMARY OF QUALAFICATIONS: * Twenty years of Health Care experience - Admin. & Management. Eleven years in the Biotech / Pharmaceutical Industry. * Clinical Research - (CRA, CRC, Consultant) - FDA Compliance/Quality, Systems/cGMP, GLP, GCP

Tags for this Online Resume: Management, Compliance, Quality, Quality Assurance, Assessments, Audit, Cancer, oncology, clinical, trial, gcp, protocol, pharmaceutical

Chemist - 8 Years of Experience - Near 08855

SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and ...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, SEC, Securities and Exchange Commission (SEC), Support, Instrumentation, Audit, Good Laboratory Practices, Good Manufacturing Practices, oncology, phase, protocol, pharmaceutical, clinical