Senior Validation Consultant
2 weeks ago
About the Role
KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality.
We are seeking a Validation Consultant to aid with the validation process.
The consultant will be responsible for ensuring standards and contributing to the development of an ISO certification framework.
Key Responsibilities
- Initiate and manage the validation process for client applications, ensuring compliance with CSV standards.
- Collaborate with development and design teams to gather and document user requirements, product specifications, and detailed design.
- Oversee the execution of the validation process, including development, testing, and backlog management.
- Conduct a gap analysis to identify areas of improvement for CSV, IT Security, and ISO certification frameworks.
- Develop a roadmap for implementing an ISO 27000 or ISO 27001 framework to ensure data security and compliance.
- Collaborate with stakeholders to define validation requirements, timelines, and deliverables for each client application.
- Ensure accurate documentation storage in JIRA and approvals through DocuSign.
- Provide regular updates to clients, project teams, and management regarding validation process progress.
- Collaborate with internal teams and external consultants to address technical challenges and ensure successful project completion.
Requirements
- Bachelor's degree in computer science, engineering, or a related field.
- Fluent in English, both written and spoken.
- Minimum 5 years' experience in Agile CSV and IT Security, preferably in the pharmaceutical industry.
We Offer
- Flat hierarchies and responsibility from the beginning.
- People-oriented culture.
- Diversity and inclusion-focused environment.
- Global client projects in a multinational environment.
- Flexible working hours and home office.
- Involvement in global conferences.
- Individual professional development, training, and coaching.
- Unlimited full employment contract.
- Excellent remuneration package consisting of a competitive salary plus a substantial bonus.
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