We have an Urgent opening .Please see the Job Description Below and let me
know if you have any consultant available.
*Role Validation Analyst *
*Location: Foster City, CA*
*Duration: 6 months +*
*PRIMARY DUTIES AND RESPONSIBILITIES:*
Mandatory Technical Skills
• Strong hands-on experience in Software testing in the Pharmaceutical
and/or Medical Devices industries
• Experience in Software validation and compliance activities in pharma
• Experience in working with GxP, SOX, Data Privacy applications
• Should have good understanding of change management process
• Experience in the use of HP Quality Center and similar tools to manage
software testing and requirements
*Functional Skills *
1. Experience in Information Technology, hands on computer system
validation activities. Worked in cGMP, 21 CFR Part11 and GAMP 5
environment. Hands on authoring/ review/ approval of computer system
validation deliverables, inclusive of requirements gathering. Functional
specification, test/validation plans, protocols, test scripts / cases,
traceability matrix and summaries.
2. Experience in the pharmaceutical or biotech industries supporting IT
3. Demonstrated skills for independently guiding quality and compliance
activities during system application design, development and deployment in
the pharma industry.
4. A minimum of a Bachelors degree in sciences
5. Demonstrated ability to communicate effectively with individuals and
groups at multiple levels across the organization
6. Ability to work independently, manage multiple priorities, and work in
an unstructured environment
7. Experience managing activities within medium to large scale IT projects
8. Experience with risk based approaches to validation (GAMP 5)
*Wasim AhmedUnited Software Group Inc.. 565 Metro Place South. Suite #
110 Dublin, OH 43017 Phone: 614-495-9222 ext 494
<614-495-9222%20ext%20494>Fax: 1-866-764-1148 <1-866-764-1148> *
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