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Online Resumes with "FDA Regulations"
Sr Business Analyst - Continous Improvement ; Lean Expert with 20 yrs experience in Mgt., Operations and Engineering of Medical Device Products. Work well with all levels of management and
I am an experienced manager looking for a rewarding path to senior, executive management position. Prefer to stay in Medical Device but will consider other possibilities in other industries.
Tags for this Online Resume: Lean Leader - Problem Solver, Production Manager, Quality FDA Regulated, Medical Device Expert, ISO, Quality Assurance, Engineering, Lean Leader - Problem Solver-Contiuous Improvement, Continuous Improvement
formulation scientist
• Knowledge of current manufacturing, production technologies, formulation guidelines, GMPs and FDA regulations • Acumen to prototype formulation development, analytical method development, scale-up, validation and technical evaluation of multiple dosage forms, which includes controlled as well as immediate release solid, semisolid & liquid dosage form • Knowledge for Transdermal Drug Delivery System • Accustomed to work in...
Publications Manger
Ideal Companies: GlaxoSmithKline, Novartis, Wyeth, Syngenta, BASF
Tags for this Online Resume: technical writer, validation specialist, analytical chemist, publications manager
Biologist- 12 years experience - West Point, PA
Highly organized, self-motivated Research Biologist with 12 years’ experience in pharmaceutical research conducting preclinical studies in 5 animal models. Recognized for excellent communication and technical skills, ability to adapt to unexpected circumstances and effectively prioritize tasks; works well in a group and independently.
Ideal Companies: Merck, Johnson & Johnson, GlaxoSmithKline, Charles River, Icon, Other smaller CROs
Tags for this Online Resume: Preclinical Toxicology Studies, Data Management, Animal Research, Documentum, First Doc, GLP guidlines and FDA regulations
Senior IT Solution Delivery Leader: 3 years Global IT Chief, 5 years SAP Strategy & Implementation Consulting, 8 years SAP Pre-Sales
A role where I can (1) develop partnerships with my customers, (2) collaborate with them to visualize the ideal future and (3) lead a team to systematically make that vision a reality.
Ideal Companies: GE, McGladrey, Capital Group, SAP, IBM, Deloitte, KPMG, CSC, PWC, 3M
Tags for this Online Resume: CIO, Director, Program Manager, Project Manager, SAP, Delivery
Senior Business Analyst
I am a Senior Business Analyst with project management experience supporting application development, security and release management. Knowledge of HIPAA, PCI, PSI, and FDA regulations to establish system requirements to meet internal and external audits. Over twenty years of customer and technical liaison support in the health care organizations and a medical device manufacturing and distribution company. Proficient in w...
Tags for this Online Resume: Project Management, Requirments Development, Agile, SDLC, San Diego County, Testing
Process Engineer, Quality Engineer/Engineers, Bay Area, California
To have a challenging position in Process Engineer, Quality Engineer/Engineers, where I could apply all major principles of design and engineering such as implementing manufactures processes, maintaining and improving new products for production line, and transferring designs into manufacturing to ensure that product is manufactured to meet compliant regulatory requirements such as cGMP’s, QCEM, validation, ISO13485:2003, ...
Research Scientist; Sub-Investigator; Research Physician for 8 years
Tags for this Online Resume: Medical Science Liaison, Clinical Research, FDA regulations, Psychiatry, Neuroscience, GCP
Pharmaceutical Professional (Quality/Compliance/Coordinator)
Pharmaceutical Professional who has more than 6 years experience in various roles within FDA regulated Pharmaceutical industries. Expertise in Research and Development, Quality Control, Quality Assurance, Professional Report Writing supporting Regulatory aligning company policies and industry standards. Project Management. Excellent interpersonal skills
Vice President Marketing, Product Management and Business Development
Successful career in marketing, sales management, business development in the medical device and biotechnology vertical markets. Proven experience in business development through strategic visioning, alliance partnering, technology licensing, product development, channel selection and development, for start-up to multinational corporations. Products include; imaging devices, capital equipment, implantable devices, web-bas...
Tags for this Online Resume: Marketing , Product management, Business development, International experience, Medical device and , Vice president
Quality Engineer - 20 Years of Experience - Near 30022
I have been involved with numerious FDA regulated manufacturers in both the pharmaceutical as well as the medical device industry sectors in supporting them in meeting their FDA warning letter violations. These directives encompass 21 CFR Part 210 / 211 and 21 CFR Part 803, 806, 809 & 820 compliance statues. I pride myself in assisting team members in not only understand what the FDA is asking of them, but to enhance the ...
Tags for this Online Resume: quality assurance, regulatory compliance, engineering
Clinical Quality Assurance - 20 Years of Experience - Near 60090-2220
Reliable, dedicated professional with extensive experience in a wide range of areas within the pharmaceutical environment, including formulation, analytical lab testing, batch record review, documentation, clinical packaging, data review, auditing, CAPA, instrument calibration and training programs. Personable team player, conscientious, reliable, and flexible. Detail oriented, enjoy working with data and numbers and findin...
Tags for this Online Resume: GMP , SOP Revision, Training , Documentation, Calibration , Investigation
