Validation Consultant
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Our client, a leading life sciences organization, is seeking a Validation Consultant to support their digital technology compliance team. The project focuses on managing the lifecycle of computer systems and supporting IT quality processes within research and development environments.
Responsibilities
- Establish quality frameworks to maintain computerized systems in compliance with internal and external regulations such as data privacy and cybersecurity.
- Ensure project deliverables are complete, consistent, and delivered according to project timelines.
- Support the creation and review of validation and qualification SOPs and templates.
- Resolve computerized system validation and qualification compliance issues.
- Manage quality events including change controls, deviations, and CAPA.
- Communicate effectively with multidisciplinary stakeholders across research, development, and security departments.
Requirements
- You have a Bachelor or Master in Computer Science, Life Sciences, or Engineering.
- You bring 5+ years of experience as a validation consultant or quality manager for computer systems within GLP and GCP regulated environments.
- You possess deep knowledge of FDA 21 CFR Part 11, EU Annex 11, and ICH Guidelines regarding data management.
- You have expertise in Data Integrity controls and risk assessments using GAMP 5 or CSA frameworks.
- You bring experience managing early drug discovery, clinical, and pre-clinical biomarker research data within cloud-based R&D platforms.
- You have knowledge of AI governance frameworks, including Generative AI and LLMs.
- You're an autonomous professional with a critical mind, high attention to detail, and a pragmatic approach.
- You are fluent in English.
Nice to Haves
- Experience with software systems such as Veeva, QMS, ServiceNow, or Jira.
- Proficiency with the latest MS Office software package.
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