Validation Lead
5 days ago
We are seeking a highly skilled Validation Lead - GxP Compliance Expert to join our team at Maxis Clinical Sciences. This is an exciting opportunity for a seasoned professional to lead validation efforts and ensure compliance with GxP regulations.
Key Responsibilities- Develop and execute validation strategies, protocols, and documentation plans for systems, processes, and equipment in GxP-regulated environments.
- Collaborate with internal stakeholders to coordinate validation activities, including scheduling, resource allocation, and communication of validation status.
- Review and approve validation documentation, ensuring compliance with regulatory requirements and internal quality standards.
- Provide technical expertise and guidance on validation activities, including troubleshooting issues and resolving deviations or discrepancies.
- Stay current with changes in GxP regulations, guidelines, and industry best practices related to validation.
- 5+ years of experience in an FDA-regulated environment.
- 5+ years of pharmaceutical Quality Assurance or Validation experience is preferred.
- Strong understanding of GxP regulations, including GDP, GLP, GMP, and GCP requirements, as well as validation principles and methodologies.
- Strong functional knowledge of Pharmaceutical Manufacturing and Quality Process.
B. Pharm/B. E or above from a Reputable Institute.
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