CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "EMA"

Proven, Global Marketing, Sales and Business Development Leader

A directing role in business development, marketing, sales and licensing in an organization that will capitalize on my skills in market development, licensing, and strategic planning.

Tags for this Online Resume: marketing sales business development international

Microbiologist - 20 Years of Experience - Near 45066

Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...

Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures

Clinical Research - 20 Years of Experience - Near 60202

QUALIFICATIONS * Internist with 20+ years experience working in the the pharmaceutical industry including small, medium and large pharma, CRO and biotech in the USA, Canada, LatinAmerica, and Europe (including Eastern Europe), and Russia. * Board Certificatioon in Internal Medicine and training in Critical Care Medicine. Clinical practice experience in Hospitals, Emergency and Critical Care settings. * Extensive experience ...

Tags for this Online Resume: Project Leader, Executive Medical Director/VP, Protocol, Cancer, COPD, Critical Care - Respiratory, OTC, Clinical Programs, Research and Development, CardioVascular, Pain & Inflammation

Quality and Regulatory Compliance

SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...

Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services

Pharmaceutical Scientist

SUMMARY * Scientific Leadership-Pharmaceutics. Wealth of experience (>25 years) in delivering impactful products to the market through Formulation/Process development (solids, liquids, and parenteral dosage forms) and Analytical development. Key example: Lexapro marketed by Forest. * Organizational Leadership and Mentor. Scientific organization management that focused on learning and delivering results. Underlying philosoph...

Tags for this Online Resume: Management, Business Development, Documentation, MOS, Pharmaceutical, Due Diligence, Manufacturing, Packaging, Process Improvement, Quality

Clinical Quality Assurance - 20 Years of Experience - Near 60559

SUMMARY Acting Site Head Quality for XELLIA Pharmaceuticals - Facility was under Consent Decree-FDA Director Global Quality Ops-Tech Services Injectable Vertical, in Bangalore INDIA, MYLAN Inc. Director Validation & Tech Services, MGP a Wockhardt, Ltd, company. Built for the Aseptic Filling, Formulation Equipments and Computer Systems and IT-Automated Systems in RM. SME in FDA, TGA, EMA/MHRA Audits for Tech Transfer and Hos...

Tags for this Online Resume: BMS, CMOS, Siemens, Apollo, Assembly Line, Insulin, Management, Program Manager, Project Management, Quality, QA/QC CSV

Advertising - 20 Years of Experience - Near 40205

Bryan Sethre 502 381 6088 1833 Bonnycastle Av Louisville Ky sethre555@gmail.com Creative Diretor  the watsons NYC i have been freelancing for friends of mine who have their own agency. 10 - 40 hours a week. And that's about it for the last 15 years - and i'm getting awfully tan by the lake. It's time to get back to work. VP Creative Director  Bernard Hodes Group  2000 i was hired for three months to restaff a creat...

Tags for this Online Resume: Hub, ACD, Automatic Call Distribution, Management

Biologist - 7 Years of Experience - Near 91346

SUMMARY As a Quality Manager, my job is to ensure the quality of our product. Without controlling the quality of our product, there is no product. My skills and abilities are the following: strong knowledge of ISO, GMP, GDP, SOP, and GLP ~7 years of quality systems and quality oversight calibration of medical devices to ensure validation controlled temperature chambers (CTC) raw materials handling and testing ~5 years of ou...

Tags for this Online Resume: Inventory, Microbiology, Payroll, Chemistry, Media Preparation, Documentation, Quality Oversight, Quality Management, Supervise, FDA, GMP, EMA, GDP, Compliance, Raw Materials, Quality Assurance, Quality Control, Sampling, Audits, Biology, Human Factor VIII, QCA, Biotechnology, Pharmaceutical, GLP, ISO, CAPA

Not Listed - 20 Years of Experience

CAREER SUMMARY Present: Industrial Hygiene Supervisor, Safe State / The University of Alabama. - Conduct onsite OSHA consultation to 100s of Alabama's small business. - Subject matter expert in OSHA standards. - Provide technical advice to employers on recognition and abatement of hazards. - Promote speaking engagements, publicity displays, and training seminars. - Hold qualification of Certified Industrial Hygienist (numbe...

Tags for this Online Resume: HYGIENE, Leadership, Noise, Occupational Safety and Health Act, OSHA, Radiation, Toxicology, Training

Quality Assurance Director - 11 Years of Experience - Near 07076

SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...

Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development

Army - 20 Years of Experience - Near 46143

SUMMARY Highly experienced Senior Quality Assurance Manager and Military Veteran with a Security Clearance and 20+ years of proven experience in supply chain management in the Department of Defense, public and private sectors. Possess extensive knowledge in General Management and Supervisor Operations as well as FDA, EMA, OECD and LGS Quality Systems Regulations. Expert in ensuring compliance, identifying and implementing q...

Tags for this Online Resume: Quality Assurance, Test, Customer Service, Quality, Quality Control, Defect Tracking, Help Desk, Information Technology, Manufacturing, Project Leader

Manager - 20 Years of Experience - Near 29464

Qualifications Summary Over 25 years' experience as a manager, organizer and action oriented forward-thinking decisive leader in highly dynamic fast-paced environments with comprehensive knowledge of Federal Acquisition Regulation (FAR) and Department of Defense (DoD) procurement policies and procedures. Extensive experience directing project team personnel, managing cost and schedules, ensuring contract compliance, and ser...

Tags for this Online Resume: management, manager, DoD, TS/SCI, Active Security Clearance - TS/SCI, Program Manager, Program Management, Project Management, Project Manager