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RESPONSIBILITIES :
Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance CSA ), and good understanding of electronic record / signature management practices.
Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews / Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
Author, review and / or approve applicable CSV documentation.
Perform or oversee test script execution efforts, including defect management.
Ensure validation test strategies align with internal procedures and requirements for intended use.
Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
Experience in following CSV methodology for system evaluations, changes, and implementations.
Ability to work independently.
Requirements :
Last updated : 2024-06-13
Full Time
$87k-107k (estimate)
05/22/2024
06/14/2024
katalysthls.com
South Plainfield, NJ
<25
The job skills required for Validation specialist include Computer Systems, Problem Solving, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation specialist positions, which can be used as a reference in future career path planning. As a Validation specialist, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation specialist. You can explore the career advancement for a Validation specialist below and select your interested title to get hiring information.