Validation Lead
$50 - $55 per hourCynet Systems
Job Overview:
Pay Range: $50.00hr - $55.00hr
Requirement/Must Have:
Pay Range: $50.00hr - $55.00hr
Requirement/Must Have:
- 7-10 years of relevant experience in Infrastructure Qualifications and Business Systems Validations.
- Experience leading or advising junior and senior resources.
- Specific experience in the pharmaceutical, biotechnology, or medical device industry.
- Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation.
- Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts.
- Experience in writing and executing documentation for all aspects of validation deliverables including requirements, compliance/validation plans, test protocols, test summary reports, and SOPs/WIs.
- Experience in reviewing system test and user acceptance test scripts, traceability matrices, and design specifications.
- Experience in QA methodologies, including designing, reviewing, and approving test plans and procedures.
- Strong verbal and written communication skills.
- Independently support business separation activities for large global and regional GxP computerized systems with minimal supervision.
- Manage end-to-end processes from inventory and assessments to remediations and final dispositions.
- Define and implement risk-based validation activities.
- Review and approve test plans, systems, and UAT test scripts.
- Recent experience with acquisitions, separations, or divestitures within a similar organizational environment.
- Computer System Validation.
- M&A Data Migration.
- Infrastructure Qualification.
- Data Platform Domain.
- GxP Standards.
- Risk Based Validation.
- QA Methodologies.
- UAT Testing.
- 7-10 years of relevant experience in Infrastructure Qualifications and Business Systems Validations.
Vacancy posted 4 days ago
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