We have a below urgent requirement from our client.
Please let me know if you have any suitable consultants for the below
*Subject: Validation Analysts*
*Location: Rockville, MD*
*Duration: 3 months +*
*Experience and Education Requirements*
BS or higher Degree in Computer Science or equivalent experience.
5-7 years in related field, preferably healthcare. 3+ years experience
applying regulations (FDA, 21 CFR Part 11 and/or 820, etc.); very strong
software technical aptitude, including experience with Microsoft platforms
(such as ASP.NET, C#, VB Scripting), SQL, PL/SQL, SQL Server, Crystal
reports, Oracle or other relational databases, Java scripting, Web and
client server applications, SharePoint, MS-Project, Visio, test automation
and test tracking tools, configuration management tools and electronic
document management tools.
*Minimum Skills, Knowledge and Ability Requirements*
Expertise in all phases of Software Development Life Cycle (SDLC) and
Computer System validation (CSV)
Working knowledge of FDA/cGXP; Strong working knowledge of Pharmaceutical
(21 CFR 11 and/or 820) Regulations and software technical aptitude.
Ability to prepare, execute, and analyze validation studies and Validation
Master Plans; Ability to communicate project status, issues, risks, plans,
etc. within the organization.
Demonstrated experience working in a regulated environment requiring
adherence to government or regulatory body policies and procedures.
Demonstrated knowledge of Quality Management Systems tools. The personnel
should be able to lead software validation projects and change control
Able to respond/react with appropriate urgency/professionalism and make
decisions under pressure. Supports goals and initiatives tied to the
Quality Plan and departmental goals.
Ability to interface effectively with cross-functional teams resulting in
overall regulatory compliance.
Thanks and Regards
* IT Recruiter*
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