We are looking for *Validation *for one of our known client In *CA, *if you
are interested please respond to this email with you are word updated
resume with expected hourly pay rate.

*Role                 : Validation     *

*Location          : West Lake, California *

*Duration         : 6+ Months*

*Rate                : OPEN      *

*Need Resumes with SLC, SQA, strong knowledge of FDA, HIPAA and HITECH
guidelines related to SQA.*

*Job Description:    *

Provide Software Quality Assurance services for regulated/non-regulated
computerized systems assuring computerized systems adhere to quality
standards and applicable regulations throughout the system's life cycle.

Specific tasks include but not limited to:

•           Validation Master Planning for IT Systems

•           SLC Review board sponsorship

•           SLC deliverable review and approval

•           Requirements / traceability verification

•           Certification Summaries

•           IT System Production Incident Reports

•           IT System Exception Report support

•           Policy / procedural changes and approvals, as appropriate

•           Audit / inspection support

•           Periodic reviews

•           IT Supplier/Service Provider Evaluation review and approval

•           Operations SQA Library Administration

•           Corporate/Divisional Compliance Plan implementation and support

•           Be a subject matter expert in Software Quality Assurance
processes, specifically with respect to Care Models

•           Be empowered to guide and make recommendations to the Brands
for projects that may be unique in nature

•           Serves as a strong liaison and coordinator between SQA, IT and
Brand Teams for SQA activities

•           Have a working knowledge of ePASS Promotional Projects process

•           Provide step-by-step guidance, mentorship and trainings to
Brand IT and Business teams to successfully complete SQA related processes

•           Communicate closely with Brand Stakeholders including weekly
status reports and assist in project activities where needed

•           Have strong knowledge of FDA, HIPAA and HITECH guidelines
related to SQA processes, specifically as we work with external SaaS vendors

•           Have at least 2 years of project management / coordination

•           Preferably possess BioPharma IT and Health IT experience as we
may work on integrating datasets from Health Systems, HCPs, Pharmacies,
Labs etc.

•           Keep up to date with relevant industry knowledge, trends,
technologies and federal / state regulations

*Thanks and Regards*


*IT Recruiter| Ven Soft LLC*

*4221 Walney Road, suite 500, Chantilly, VA 20151*

*Office: **703-763-2541 (896)* *| Fax:* *732 875 0535*

*Email id:* *ri...@vensoftllc.com <ri...@vensoftllc.com>*  *|
<http://www.vensoftllc.com/> *

*Ven Soft LLC is ranked 616 – on the 2014 Inc. 5000 List and
is successfully providing full IT consulting services to Fortune 500 firms
with offices all over US and with headquarters in Fairfax, Virginia*

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