CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "validation protocols"

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

Chemist - 20 Years of Experience - Near 12122

Profile: Experienced Analytical Chemist * Self-motivated, result driven, detail oriented individual, works well as a team member or independently, willingness to learn * Strong background in GMP/GLP, analytical and wet chemistry * Well-versed in USP, EP and JP policies and procedures, chemical hygiene and safety policies * Analysis and release of raw materials, finished products, in process, and stability samples * Method d...

Ideal Companies: Pfizer, GlaxosmithKline, Astrazenica

Tags for this Online Resume: Audit, Documentation, Kaizen, Management, Packaging, Quality, Quality Assurance, Quality Control, EP, pharmaceutical, Quality control, Laboratory, analytical, chemist, GMP

General - 13 Years of Experience - Near 10701

Summary of Qualifications Enthusiastic, self-starter with the ability to present products/ideas persuasively and build rapport. Flexible, multi-tasker with a strong work ethic and ethics and character of the highest caliber. Creative, attentive to the completion of precise tasks and projects. Enjoys taking initiative beyond stated job and is sensitive to needs of others. Qualified professional providing expertise in the lab...

Tags for this Online Resume: Technical Writer, Quality Assurance, Regulatory Affairs, Research, Compliance, Manufacturing, Quality, Quality Control, Documentation, Reliability, Research and Development, Document Control, HIV

Microbiologist - 20 Years of Experience - Near 07753

Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...

Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap

Project Manager - 15 Years of Experience

Career Highlights Conducted requirements analysis and user feedback sessions (internal users to members of Congress) and provided summary analysis with recommendations for user experience improvements. Produced next generation site with more intuitive user interface. (Canton Group) Managed successful launch of portal for Audi of America (AoA) by leading requirements gathering, prototyping, client feedback, presenting update...

Ideal Companies: Frog Design, Google, uShip

Tags for this Online Resume: Product Development, Test, Test Plans, Management, Medical, Project Management, Protocol, Troubleshooting, Applications, Cascading Style Sheets, agile, software, html, requirements gathering, QA

Life Scientist - 20 Years of Experience - Near 02642

SUMMARY IT/QA PROFESSIONAL Biotech - Pharmaceutical - Medical Device - Life Sciences Highly skilled consultant and Project Manager with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills. Hold proven record of success in product development, process improvement, cGMP compliance, validation and quality control. Examples: * Software Implementa...

Tags for this Online Resume: Software, Compliance, HVAC, Management, Support, Assessments, Automation, Integrate, Manufacturing, Millenium (Sw-Fin/Admin), gcp, pharmaceutical, sas, protocol, clinical

Quality Assurance Specialist - 13 Years of Experience - Near 08540

Professional Summary More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis Data Analysis and Management Software Application Testing Document Management Change Control and Release Management FDA Compliance Verification and Validation Quality Assurance Processes and Methodologies Developing Testing Strategies and Test Plans Test Scenarios and executing ...

Tags for this Online Resume: Test Scripts, Test, Management, Test Cases, Structured Query Language, Audit, CFR Part 11, Test Plan, Application Server, Documentation, validation of protocols

Electrical Engineer - 18 Years of Experience - Near 00957

QUALIFICATIONS / EXPERIENCE Over Nineteen (19) Years in Pharmaceutical and Biotechnology Industries and Projects Development as service representative, working in engineering design, instrumentation and controllers. Also have been specializing in systems and equipment qualification and GxP validation. Construction: Strong Experience in Commissioning Engineering, FAT (Factory Acceptance Test), SAT (Site Acceptance Test), SIC...

Tags for this Online Resume: Honeywell, Pharmaceutical, Protocol, Assessments, Automation, Distribution, Engineering, Applications, Cadence, Centrifuge

Team Leader - 20 Years of Experience - Near 32934

Experience Summary Experienced IT professional with solid leadership track and expertise in managing multiple infrastructure, operational, development and architecture projects. Productive self-starter and innovative out-of-the-box thinker, expert in all aspects of systems implementation and integration, server and storage development, and networking, as well as, systems and services acquisitions, testing and validation, ad...

Tags for this Online Resume: Management, Structured Query Language, Business Process Management, C# Programming Language, Desk Top Support, Desktop Computer, EDP, Endpoint Security, Information Technology, it jobs, Team Lead, Systems Analyst

Regulatory Affairs Specialist

I am Yashica, working as a Regulatory Affairs Specialist and open for new job opportunities. I possess Masters Degree in Regulatory Affairs and have a working experience of Two Years (Plus a research Experience in Regulatory and Clinical area for two years). I am able to work in a Matrix and fast paced environment where one needs to prioritize the tasks and complete in a timely manner. I have handled projects independen...

Tags for this Online Resume: Regulatory Affairs, CMC, Labeling, Submissions, Regulatory Strategy , Clinical

Production Manager - 20 Years of Experience - Near 32825

PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...

Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management

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