Validation Manager
hace 2 semanas
Main tasks and responsibilities:
- Develop and document validation strategies for complex projects, considering both business needs and regulatory requirements (GxP, FDA, etc.).
- Define and implement validation approaches to meet project specifications, collaborating with the client's internal Quality department.
- Champion the One Medicine Platform's adoption of the DevOps Model within the validation framework.
- Lead and coordinate the validation process, effectively communicating and negotiating deliverables with stakeholders.
- Prioritize tasks and manage time effectively to ensure timely project completion.
- Present and defend validation concepts to compliance offices and regulatory authorities during audits and inspections.
Requirements
- Bachelor's or Master's degree in IT, engineering, sciences, pharmaceuticals, biotechnology, or a related field.
- Strong understanding of analysis and user requirement engineering methods.
- Excellent written and verbal English communication skills.
- Experience in project implementation using computer validation regulations and methods (SOPs, GCP, FDA Guidelines, CFR 21 Part 11) and data integrity principles.
- Passion for teamwork and fostering collaboration in diverse technical and cultural environments.
- Prior experience with Agile methodologies is a strong asset.
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