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Online Resumes with "GCP GLP"



Project Manager, Clinical Trials

I am interested in a Project Manager or related position requiring multitasking and organizational skills to oversee multiple projects. I have eight years experience in the biotech/pharmaceutical industry. With the scientific, laboratory and management skills I have accrued over the years, I can perform tasks without supervision. I am looking for a position that allows further personal and professional growth.

Tags for this Online Resume: Global Clinical Trials Project Management, ICH, GCP, GLP knowledge, Research Associate , Independent Research , Preclinical trial management, Oncology/Chemotherapeutic drug discovery and development

Clinical Trials Manager

Dear Hiring Manager, I am interested in exploring career opportunities with your company and have therefore enclosed my resume for your review. This position seems ideal for my experience, education, skills, and career interests. I am eager to contribute my enthusiasm and teamwork to your organization. My professional goal is to enhance my research development and senior leadership experience. I believe that I could...

VP Quality and Compliance - GCP, GLP, GMP, PV; Pharma and Med Device Experince

Clinical Quality Assurance - 7 Years of Experience - Near 02910

Seeking a position in a professional and organized atmosphere that will enable me to use the skills I have developed in my previous work experience. I have the ability to work both independently and be an integral part of a team. I will strive in areas where I can be creative, take Initiative, detail oriented and be allowed to use those strengths in solving problems

Tags for this Online Resume: Quality Assurance, document Managment System, controlled documents, GMP, GCP and GLP operations, Project Managment, Powerpoint, Excel, Adobe

Clinical Research - 10 Years of Experience - Near 27511

Highly motivated and detail-oriented professional with 11 years of well-rounded experience in CLIA, cGMP, and GCP/GLP environments. Seeking to improve knowledge and skills in the healthcare industry. Proven laboratory skills and Good Laboratory Practices. Demonstrated integrity in data recording and following SOP requirements in a regulatory environment.

Tags for this Online Resume: RTP, Project Management, Quality Control, cGMP, GLP, Data Integrity, Laboratory

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 In-house Monitoring - 6 Years of Experience - Near 07621

SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...

Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research

Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate

Business Analyst - 17 Years of Experience - Near 11725

SUMMARY Business Analyst / Validation Lead / Specialist / IT/QA Compliance Specialist with Pharmaceutical, IT, Manufacturing and Software QA experience: An IT professional with extensive experience in QA/Compliance, Testing, SQA, PM, Validation and Documentation specialties include: * Business Analyst experience consists of specializing in writing business workflow processes and translating them into Business, Functional an...

Tags for this Online Resume: Compliance, Information Technology, Test, Quality, Training, Good Clinical Practices, HP, ISO, Good Laboratory Practices, Manufacturing

Business Analyst - 7 Years of Experience - Near 08817

Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...

Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project

Business Analyst

SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...

Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11

Clinical Research - 3 Years of Experience - Near 02478

Summary: MS in Clinical Investigation with 3+ years of experience as Clinical research assistant cum coordinator seeking a preferably full time position in Clinical Research fields as Clinical Trial Associate / Project Management. Offering combination of strong background in biological sciences (specialization in Oncology, Molecular biology) as well as deep understanding and knowledge of ICH-GCP & FDA regulations. Demonstra...

Tags for this Online Resume: Clinical Research, Documentation, Research, Advertising, Audit, Budgetary, Data Entry, Data Management, Filing, Gastroenterology, Recruting, IRB admministration, regulatory, phase ii, clinical trials, ICH-E6 GCP and GLP, HIPAA compliance