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Online Resumes with "21 CFR"
Position as a Senior Information Technology professional using my experience in personnel and project management leading IT services for the development and production of software products.
Senior level experience in product lifecycle: personnel management (client & team), project planning, budgeting, requirements and analysis, design, risk management, coding / manufacturing, quality assurance, systems integration, validation & verification, release, support, maintenance, and auditing.
I thrive on learning new things and constant changes. Leading edge does not turn me away. Currently working in Switzerland and seriously looking to relocate to Asia for good opportunity.
Looking for a position where I can continue helping companies better utilize their technology by developing/enhancing processing or business intelligence applications or in a business/system analyst role.
To further my career in Supply-Chain Mgmt and Purchasing by offering 7 years of process improvements and cost saving strategies. I earned a Bachelors degree in Business Management with woking knowledge of FDA 21CFR820, ISO 13485, and ISO 9001.
Accomplished Regulatory Analyst with expertise in all stages of drug lifecycle management and experience in strategy implementation and submission management, eager to contribute to the success of a progressive organization. Proven success in achieving and exceeding company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives. Adept at recognizing and analyzing several the...
Engineering Manager - 10+ years experience - ISO-13485, 21 CFR 820/211, cGMPs, Lean/Six Sigma, Project Management.
To obtain a management level Engineering/Manufactiring/Operations within regulated Medical Devices/Biotech/Pharma/Food Industry where I can utilize past experience in Manufacturing support, process developement, process improvement and product sustaining.
Quality Laboratory Manager and Lab Informatics Project Manager - 13 years of experiece at Johnson and Johnson
- Project Manager/Business Analyst in Lab Informatics - Laboratory Manager/Supervisor
Tags for this Online Resume: LabWare LIMS, People Leadership, Project Leadership, Business Analyst, • Quality and Customer Advocacy, • Computer Validation and Risk Analysis, • Training and Curriculum Development, Six Sigma, 21 CFR Part 11
Started as a research assistant for a company that markets specialty clay for additives in polymers. Was listed as inventor on three patents. After a short assignment at a food company, moved into validation and quality work in the pharmaceutical industry.
Looking for sales or account management in the scientific vertical. I have over 15 years selling into Life Science, Pharmaceutical, Government, Educational and Chemical markets. Technical ability to sell complicated enterprise software to "C" level management. I take a consultative approach and would be considered a Hunter in the sales process.
Tags for this Online Resume: chromatography, Scientific Software, Scientific Distribution, HPLC, Life Sciences, 21 CFR Part 11, Validation, serevices, bio informatics, informatics, SDMS, technology, sales, hunter
Results-oriented with reputation of critical quality analysis and enhancing customer satisfaction. Effective in streamlining processes to speed project deliverables.
I am looking for a pharmaceutical operations management position where I can utilize my advanced chemistry degree, expertise in quality assurance and background in safety compliance.
Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.
Tags for this Online Resume: Develop, maintain and manage appropriate study documentation, Developing, writing and presenting the clinical trial protocols, Initiate, maintain and reconcile Trial Master File., Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise., Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data., Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines, Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines., Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned