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Senior Validation Lead
2 months ago
About the Role:
RIT Solutions, Inc. is seeking a highly experienced Senior Validation Lead to join our team. As a key member of our validation team, you will be responsible for ensuring that our software solutions meet the highest standards of quality and regulatory compliance.
Key Responsibilities:
- Lead the validation process for our software solutions, ensuring that they meet the requirements of GxP regulations and industry standards.
- Develop and implement validation strategies and plans, including risk assessments and criticality evaluations.
- Collaborate with cross-functional teams, including development, quality, and regulatory affairs, to ensure that validation activities are aligned with business objectives.
- Provide guidance and training to project teams on validation processes, procedures, and tools.
- Manage and prioritize validation projects, ensuring that they are completed on time and within budget.
- Perform periodic reviews and CAPA management to ensure that validation activities are effective and efficient.
Requirements:
- 10+ years of experience in Computer System Validation, Quality Management, or Business Analysis in a GxP application area.
- Strong understanding of GAMP and 21 CFR Part 11 regulations, as well as risk-based approaches.
- Excellent communication and interpersonal skills, with the ability to interact with business stakeholders, project managers, and technology leaders.
- Experience with project management tools, such as JIRA.
- Strong analytical and problem-solving skills, with the ability to manage multiple projects and priorities.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
