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
*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
- 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
- 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
- *Experience as a project team member for the implementation of computer
- 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
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
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