Validation Lead
Validation Lead
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Salary Not Disclosed
1 Vacancy
Job Description
- Minimum 3 years experience with SAP or Blue Yonder Warehouse Management Systems.
- 3 years experience with System Development Lifecycle.
- 3 years experience in Computer System Validation.
- Experience with FDA CSA principles Experience with J&J CSV Framework Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
- Knowledge of FDA guidance and industry standards (i.e. GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements Compliance/validation Plans test protocols Test Summary reports and Compliance/Validation Reports.
- Experience in reviewing system test and user acceptance test scripts Traceability matrix and Design Specs. Experience in QA Methodologies designing reviewing and approving Test Plans systems and UAT test scripts and Test procedures.
- Strong verbal and written communication skills.
- Ability to work as a team player lead a team or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
- Ability to provide Validation guidance timely reviews and escalations to TQ management.
Employment Type
Full Time
