Hello, Hope you are doing great today, Please go through the below job description and let me know if you have any consultants interested in this position. If yes, please send their updated resume ASAP.
*Location: CA. * *Duration: 6-9+ Months.* *Job Title: Validation Engineer (Must have Health care Experience) * * Should submit the profiles on Monday. * *Job Description:** * *The Computer Systems Validation Engineer will work under the direction of Regulatory / Quality Assurance*. - Develop, in collaboration with the team members, a QA (validation) strategy and plan for the software in accordance with the company's risk based approach - Play a key role in determining what quality assurance activities are appropriate to the software being implemented *- Coordinate with project management, RA/ QA, IT, and user groups as needed to plan for and ensure the completion of the QA activities* - Provide informal training and support to the users on tasks such as: the documentation of requirements, the creation of tests, the capture of appropriate objective evidence of test results, and the handling of system failures. For some projects, the contractor will perform these activities him/herself. - Ensure that appropriate documentation is created and preserved - *In-depth experience in software / computer system validations and flexibility in the use of validation methods and techniques is a must.* - Proven experience as a member of teams that implemented computer systems for which validation is not required. *- Strong knowledge of validation regulations, guidance documents, industry standards, methods, and Part 11. Understanding of what is meant by taking a risk-based approach and experience with such approaches.* - *Ability to lead and provide support to others in collaborative efforts to create QA deliverables* - Demonstrated ability to influence project teams and individuals on computer validation matters. - Excellent problem solving and analytical skills. - Excellent verbal and written communication skills. - Ability to work independently, follow company policies, procedures, and methods; motivated self-starter; well organized and reliable. *- Ability to work as a team member.* - Commitment to quality; detail and results oriented. *- Broad knowledge of quality system regulations, such as CLIA, QSRs, GCPs, ISO 13485, ISO 14971, and the Global Harmonization Task Force guidance. Experience with quality assurance in regulated industries is a plus. *- *Knowledge of the SOX regulations and their implications for software implementation is a plus. - Experience with software development, database management, and IT experience that has provided knowledge of the IT infrastructure and its services are all pluses. * *- At least 6 years of direct responsibility for the validation of applications in the Diagnostics / Devices / Biotech / Pharmaceutical industries.** * - *Experience as a project team member for the implementation of computer systems* - Experience with the following is considered a plus: - SOX regulations - CLIA regulations - LIMS software - FDA regulations . If you are interested in this position please respond with *updated résumé, rate and Contact details ASAP*. Reply to va...@sureitinc.com or call me on 602-334-4209 - -- Thanks, Best Regards, Varma Sure IT Solutions Inc. 1801 W Queen Creek RD | Suite # 3 | Chandler | AZ 85248 Phone:602-334-4209 FAX: 866-322-0121 Email: va...@sureitinc.com, varma.sur...@gmail.com http:/www.sureitinc.com http://www.linkedin.com/in/krishvarma Arizona. (The contents of this e-mail are confidential to the ordinary user of the e-mail address to which it was addressed and may also be privileged. If the reader of this message is not the intended recipient, any dissemination, distribution or copying of the information contained in this Internet message is strictly prohibited. If you have received this e-mail in error please notify us by telephone or e-mail the sender by replying to this message, and then delete the e-mail and other copies of it from your computer system. Thank you. We believe this email to be virus free but do not warrant that this is the case and we will not accept liability for any losses arising from any virus being transmitted unintentionally by us.) --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "zilliontechnologies" group. To post to this group, send email to email@example.com To unsubscribe from this group, send email to zilliontechnologies+unsubscr...@googlegroups.com For more options, visit this group at http://groups.google.com/group/zilliontechnologies?hl=en -~----------~----~----~----~------~----~------~--~---