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Executive Order 11246, Section 503 & VEVRAA EOE, including disability/vets
GAMP SDLC Quality Assurance System Design Database Design LIMS Tester
(Jobs in S S
 
Requirement id 43431
Job title Tester
Job location in S San Fran, CA
Skills required GAMP, SDLC, Quality Assurance, System Design Database Design LIMS
Open Date 20-Feb-2015
Close Date
Job type Contract
Duration 11 Months
Compensation DOE
Status requirement ---
Job interview type ---
Apply
   Email Recruiter: coolsoft
Job Description Tester: GAMP, SDLC, Quality Assurance, System Design Database Design LIMS

Responsibilities:
* Develop test scenarios and test scripts, test plans, validation (test) protocols and test summary reports and review them with other project members.
* Develop and review validation deliverables for computer system validations, system requirements and change control activities.
* Hands-on testing and problem reporting.
* Ensure compliance with applicable regulations, guidelines and internal procedures related to SDLC, quality assurance (QA) and validation are followed and applied.
* Work with system developers, IT project teams, database administrators, validation and QA staff.
* Support multiple projects as directed and apply software testing principles and methodologies and test case design concepts to complete these deliverables in different project phases. The tests will be performed on a variety of systems and may include:
*New systems as well as for system upgrades.
*Infrastructure changes and integration points with other applications.

Requirements:
* The candidate must have a sound understanding of the principles of Computerized System validation in regulated industries (GAMP, Part 11, FDA guidelines and regulations).
* Knowledge and experience with system/database design and architecture, change control, as well as System Development Life Cycle (SDLC) and Quality Assurance (QA) methodologies is required.
* A good understanding of GLP and GCP regulations and experience in the validation of computer system used in clinical and non-clinical trials (e.g., Watson LIMS, NonMem, PKS, Clinical Data Management).
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 43431 while calling.
 
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(Tester: GAMP, SDLC, Quality Assurance, System Design Database Design LIMS in S San Fran, CA)
     
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