
Validation Professional
24 hours ago
About the Role:
We are seeking an experienced Validation Contractor to join our team in the QC Laboratory. The successful candidate will be responsible for planning and executing validation activities associated with software system upgrades and decommissioning of legacy systems in a GMP-regulated environment.
Key Responsibilities:
- Develop and review validation documentation, including URS, risk assessments, protocols (IQ/OQ/PQ), and summary reports in line with current regulatory requirements.
- Collaborate with QC and IT teams to ensure accurate integration of system requirements and compliance with data integrity expectations.
- Lead or support the decommissioning of computerized systems used within the QC lab.
Required Qualifications:
- Bachelor's Degree in Life Sciences, Engineering, Computer Science, or a related discipline.
- Proven experience in validation of computerized systems in a GMP laboratory or manufacturing environment.
- Strong understanding of GAMP 5, FDA 21 CFR Part 11, and Annex 11 requirements.
Benefits:
- Comprehensive Health & Wellness Coverage
- Professional Development Opportunities
- Inclusive Culture
- Shape the Future
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