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Were you looking for 21-CFR-Part-11 job results?
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Online Resumes with "21 CFR Part 11"
Dear Sir, I believe that my initiative drive and capability for hard work will make me suitable to your organization. I am a person who believes in career satisfaction along with care growth, and it is an organization like yours, which gives utmost priority to employee satisfaction that, will suit my career needs. Here with Iam enclosing my Curriculum vitae for your kind perusal. Hoping to hear positively from your e...
Tags for this Online Resume: Bioanalytical method development, Bioanalytical method Validation, Bioanalytical Subject Analysis in GLP conditions, Experience in LC-MSMS handling, Experience Protocal Review and Reports Review, Experience in 21CFR Part 11
I am seeking permanent opportunities as a Medical Device or Pharmaceutical Quality / Process / Validation Engineer. I have enjoyed my experiences in Software and Equipment Validations as well as Engineering Studies and Process Monitoring and Improvement.
PMI certified Project Manager • Experience includes projects in insurance and pharmaceutical sectors. • Responsible for full project lifecycle, categorization and management of issues, risks, change and quality management of project deliverables including managing 21 CFR Part 11 Validation and the associated deliverables
Over twenty years equipment and process design, installation and testing of process control and automation systems used across various industries the majority of which are pharmaceutical and food; Fortune 100 & federally regulated corporations. Extensive knowledge of multiple PLC platforms, SCADA programming, MSSQL, InSQL, and RSSQL database designs, implementations & management, InBatch, CDC’s & Wonderware’s Overall Equipm...
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Over14 years of in-depth experience in the pharmaceutical industry. Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Ms. Marilynn Goldsmith is a PMI certified Project Manager. Her experience includes projects in integrated oil, insurance, and pharmaceutical sectors. She has been responsible for the project schedule, categorization and management of issues, risks, change and quality management of project deliverables including managing 21 CFR Part 11 Validation and the associated deliverables.
Tags for this Online Resume: SDLC, Offshore Teams, MS Office, Deliverable , Validation, Quality, Team Mgmt, Issue/Risk, Management, Oracle, Database, Documentation, Oracle Database, PWC, Requirements Definition, SEC
Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.
Sr. Manager with 5 years’ experience managing individual contributors and supervisors in a global environment Proven Quality Assurance leadership skills to ensure IT/Lab/Site compliance with internal procedures and regulatory requirements Demonstrated ability to successfully lead continuous improvement initiatives with effective planning and organization skills • Lead CAPA Investigations • Host FDA/CAP/DOH/Client Audits ...