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Online Resumes with "GXP"
Director
Dedicated and Strategic QA Professional with more than fifteen years of progressive experience in both large and small pharmaceutical companies both US based and international. Extensive experience in development through commercialization of solid oral dosage products. Comprehensive knowledge of cGXP and ICH guidelines. Leader of process and manufacturing compliance, document control programs, QA analytical sciences, vali...
Tags for this Online Resume: Internal and External Audits, Vendor Management, Quality Systems, CAPA, Customer Complaints, Chemistry Machine Control
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
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
Director - 20 Years of Experience - Near 20850
Tags for this Online Resume: Licensing, Procurement, Insurance, Management, Risk Management, Documentation, Filing, HIV, Recruiting, Waste Treatment, due diligence, contracts, intellectual property, contract research organization, contract manufacturing, GXP
Supply Chain Manager - 10 Years of Experience - Near 42301
Inventory and Account Management Specialist in FDA regulated GxP environment seeks challenging position where I can utilize my skills in supply chain, accounting and software systems.
Ideal Companies: Amazon
Tags for this Online Resume: Supply Chain, Logistics, Distribution, Purchasing, Inventory, Inventory Control, Biomedical Industry, Inventory management, Management, Regulatory Affairs
Project Manager
SUMMARY Experienced IT Software professional specialized in working with clients to understand and implement requirements and applications/systems to provide business analytics and strategic solutions in various roles as a Senior Business Analyst, Senior Project Manager, Senior SFDC Architect, Senior Program Manager/Product Manager and Senior Product Owner. Collaborate with product management, engineering and other cross-fu...
Ideal Companies: program mgnt
Tags for this Online Resume: Inventory, Support, Active Server Pages, Forecast, Forecasting, Oracle, Quality, Quality Assurance, Data Entry, Planning
Microbiologist - 20 Years of Experience - Near 80503
Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...
Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing
Quality Assurance Specialist - 14 Years of Experience - Near 07871
SUMMARY Manager and Project Coordinator of Scientific Systems with over 25 years of experience in the Pharmaceutical and Scientific field. Well versed in FDA Regulations for scientific data collection validation. Proven ability to work in coordination with Clients and Project Teams to conform to FDA Regulations. Ability to meet deadlines, working independently or as a team member. Expertise includes: * Instem Centrus Suite ...
Tags for this Online Resume: Pathology, Toxicology, CVS, Pre-clinical, Validation, GLP, Legacy, Project Leader
Regulatory Affairs Specialist - 16 Years of Experience - Near 19464
An accomplished records and information management specialist with proven skill set including 16 years’ experience within records retention and information management. Focus on health authority audit preparedness, compliance, security, and lifecycle management requirements of key company proprietary media encompassing all GXP documentation. Actively liaise with internal areas and external groups including CMOs and CROs to ...
Tags for this Online Resume: Filing, Management, Quality, Quality Assurance, Quality Control, Retention, Document Management, Documentation, Information Technology, Records and Information Management, Regulatory, Operations, Record Coordinator, Compliance, Regulatory Operations
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
Quality Assurance Specialist - 6 Years of Experience - Near 75093
SUMMARY * Experienced with Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). * Experienced in Agile and Waterfall environments. * Experienced in using HP interactive products like -HP Quality Center (ALM/QC) and JIRA. * Good exposure to Web technologies like HTML, XML and JavaScript. * Experience in SQL queries and Joins (Inner/Outer) to validate data. * Experience in IVR/IWRS Testing. * Experie...
Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server, sql, java, javascript, agile, html, software
Business Analyst - 7 Years of Experience - Near 94002
Experience Summary 7 years of overall IT Experience, which includes 6 years of experience in Developing CRM solutions, Project management, business intelligence, sales and marketing excellence, sales operations and implementation of Siebel CRM applications. * I have an extensive background in Requirements gathering and the production of functional documentation. * Currently working as Advanced Business Analyst for multiple ...
Tags for this Online Resume: Oracle, Account Manager, Billing, Business Analysis, Business Analyst, Customer Relationship Management, EAI, Inventory, Management, Services, sql, java, macros, siebel
