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Online Resumes with "GMP GLP"

Chemist - 15 Years of Experience - Near 10965

I am a QC analytical scientist with chemistry/biochemistry, immunochemistry background, and certified in Quality Auditing (CQA) I have in-depth knowledge and experience of Quality Affairs and Regulatory Affairs (QA/RA). I am looking for an opportunity in Pharmaceutical/Biotech company as QA as Associate QA scientist, Quality Auditor, Compliance Specialist, or Regulatory Affairs Specialist(entry level).

Tags for this Online Resume: Regulatory/Quality Audits, cGMP/GLP, Compliance, HPLC/EMPOWER, Document Control, SOPs/Validation, LIRs/CAPA, NY/NJ

Medical Technology-11 years, Quality Assurance- 15 years, Quality Engineer 6 years, Product specialist - 4years,

Strategic Senior Product Specialist and Senior Quality Assurance Engineer with 18 ears experience driving quality initiatives for regulated Class III medical devices. Extensive knowledge of GMPs and FDA regulations. Experience includes Diagnostics and Hospital Laboratories. Unique combination of expertise in clinical developmental, implementation of new products, logistics, Root Cause and Corrective Action, cost reduction i...

Tags for this Online Resume: Logistics, manufacturing, Supplier Quality Engineer, Operations, Customer service, QA/QC testing

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

Production Sampler - 1 Years of Experience - Near L6Y 2R9

To seek the position within the field of Chemistry, to hone my laboratory skills and knowledge and gain hands-on experience and contribute in the best way with your esteemed organization. KEY STRENGTH * Excellent written and verbal communication and mathematical skill. * Excellent computer skills including MS Office-Word, Excel, PowerPoint and Outlook. * Experience within preforming basic analysis. * Ability to function in ...

Tags for this Online Resume: Test, Chemistry, High Performance Liquid Chromatography (HPLC), Its, Microsoft Office, Monitoring, Packaging, pH Meter

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

QC Chemist-15 years experiance

• Hands of experience in Chemist for Dissolution and wet chemistry in pharmaceutical • Extensive knowledge of cGMP, GLP, USP, and OSHA requirements • Successfully validated Dissolution method and cleaning validation.

Tags for this Online Resume: QC Chemist

QA/QC Management Pharmaceutical Industry 19yrs experience Pennsylvania

I am a Quality Assurance Professional with over 19 years experience in the Pharmaceutical Industry. I am looking for a challenging role in Quality Assurance Management where I can uses my knowledge of cGMP/GLP and my skills in Team Leadership, Process Excellence, Investigation/CAPA, and Validation.

Tags for this Online Resume: Analytical Laboratory Management, Process Excellence, People and Talent Development, Technical Writing and Non-Conformance Investigations, Marketed Product Stability, Method Validation and Transfer, Complaint Vigilance, Change Management

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

Featured Profile

Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021

Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...

Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India

Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment

Technical Writer

Thirteen years experience in multiple industries at all organizational levels coordinating technical documentation creation and editing while interfacing with Subject Matter Experts, on-site engineers and technicians, and business partners. Currently seeking challenging opportunity.

Tags for this Online Resume: MS Office, Adobe Framemaker, MS Project, Factory Automation, Laboratory, IQ, OQ, PQ, Validation, Commissioning

Principal Engineer

SUMMARY OF QUALIFICATIONS * Principal engineer, R&D and general management executive and scientific professional with B.S. M.S., Ph.D. and postdoctorate in science and engineering disciplines. * Successfully developed several prototypes and launched multiple FDA/CE regulated platforms, devices and Class I-II-III products and plastic consumables for medical, diagnostics, biotech and pharmaceutical applications from concept t...

Tags for this Online Resume: Orange County, CA, Medical Device, Research and Development, Principal Engineer, Manager and Director, FDA and CE regulated, Ph.D., Biotech


QUALIFICATIONS * Currently working toward the Regulatory Affair Certificate. * Extensive analytical characterization and data interpretation skills. * Experienced in very different analytical tests like Assay, Release Rate, Residual Solvents, Water Content Determination, and ID by IR, and Viscosity Testing. * Expert in handling different analytical apparatus like HPLC, GC, FTIR, UV-VIS, Karl Fisher, Colorimeter, pH meter, L...

Tags for this Online Resume: Good Manufacturing Practices, Manufacturing, Compliance, Inventory, Microbiology, Research, Quality Assurance, Test, Chemistry, High Performance Liquid Chromatography (HPLC)