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Senior Validation Specialist
1 month ago
LS Solutions Inc is seeking a Senior Validation Specialist to join our team.
Job Summary:
We are looking for a highly skilled and experienced Senior Validation Specialist to lead our computer system validation (CSV) efforts. The ideal candidate will have a strong background in GxP systems, CSV expertise, and excellent communication skills.
Key Responsibilities:
- Develop and implement CSV strategies to ensure compliance with regulatory requirements.
- Lead internal and contract resources to ensure effective CSV support for business needs.
- Collaborate with functional teams to manage risk assessments and develop mitigation plans.
- Contribute to the review and approval of CSV documentation, including specifications and validation protocols.
- Engage in vendor assessments and lead routine and complex audits of internal processes and partners.
- Provide CSV compliance support to QA and other GxP functions, identifying issues and facilitating continuous improvement.
- Prepare for regulatory inspections and assist with responses to findings.
- Update and create relevant CSV-related policies, procedures, and templates.
- Identify opportunities for enhancements based on industry best practices and regulatory requirements.
Requirements:
- Biopharmaceutical experience.
- CSV expertise.
- Strong knowledge of Tracelink and RIM.
- GxP systems experience.
- Strong communication skills.
About LS Solutions Inc:
LS Solutions Inc is a leading provider of quality assurance and compliance solutions. We are committed to delivering exceptional results and building long-term relationships with our clients.
