Quality Assurance Tester Job at SMX USA
Candidates must have
- BS or equivalent degree in math, science or engineering
- At least three years of experience in software testing, preferably in FDA-regulated environments
- Familiarity with 21 CFR 11 and Annex 11
Job Requirements will include
- Development of User Requirements Specifications (URS) to ensure requirements that are testable and 21 CFR Part 11 requirements are met
- Evaluate computer system validation activities required
- Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
- Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, final
- reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
- Execution of validation plans and validation documents for GMP computerized systems
- Work with overall project manager to include validation activities in implementation timelines
- Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
- Work closely with QA Compliance to ensure appropriate validation of cGMP computer systems
- Able to work collaboratively with all department key personnel.
- Be highly motivated, organized, and able to manage priorities
- Have high standards for quality, accuracy, and professionalism
- Have excellent communication, presentation, and interpersonal skills (English/Spanish)
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