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Senior Validation Lead
2 semanas atrás
Fusion Consulting is a global leader in business and IT consulting, specializing in the life sciences industry. We partner with top companies in pharma, healthcare, and animal health to drive business transformation and set new industry standards through innovative solutions.
We are seeking an experienced validation manager to lead and manage validation activities across various project settings, including SAP implementation, upgrade, or enhancement, and transformational projects. This role will cover qualification activities, computer system validation, process validation, and ensuring compliance with regulatory standards throughout the project lifecycle.
Key Responsibilities:
- Develop, refine, and implement robust validation strategies that ensure compliance while maintaining seamless operations.
- Lead and oversee all operational validation or quality-related activities within the client's organization.
- Ensure all validation documentation, including system lifecycle documents, change controls, reports, and other protocols, are comprehensive, accurate, and fully compliant with regulatory standards and company policies following good documentation practice.
Required Skills and Qualifications:
- Bachelor's or master's degree in natural sciences, information technology, engineering, pharmacy, or any related field.
- Proven track record of 5+ years of experience in a validation manager or quality assurance role within the pharmaceutical or life sciences industry.
- Strong knowledge and application of regulatory guidelines and standards for highly regulated environments, including GxP validation methodologies, quality management standards, and GAMP 5 & regulatory compliance.
Benefits:
- Competitive salary and benefits package.
- Flexible time off and workflex program.
- Annual training budget and continuous learning opportunities.
About Fusion Consulting
We unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients. We value employees who challenge the status quo through innovation, adapt to diverse client needs in ever-changing environments, and commit to continuous learning for themselves and their colleagues.
