Are you passionate about ensuring the highest standards in system validation?
We are currently looking for a Senior System Validation Specialist to join our dynamic team of three and report directly to the Director of Randomization, Support, and Validation.
Your responsibilities
In this role, you will define validation strategies for both internal and external systems, harmonize and streamline validation practices, and take ownership of the Computer System Validation process.
As a Subject Matter Expert, you will author essential validation documents (URS, validation & test plan & validation report), provide input for study-specific eClinical system validation tasks.
Additionally, you will work closely with our QA team to ensure compliance with Computer System Validation regulations and ensure readiness for audits and inspections, supporting them during these processes.
Your expertise will also be crucial in performing testing and validation of core internal systems and external systems according to the software supplier’s release schedule, as well as writing and updating user manuals.
You will also play a key role in the training and coaching of junior System Validation Specialists, fostering their growth and development within the team.
Minimum Requirements
1. University degree in life science or computer science;
2. Extensive experience (at least 5 years) in computer system validation related to Clinical Trials;
3. Familiar with US & EU regulations regarding Computer System Validation;
4. Knowledge of 21 CFR Part 11, GAMP 5 and the EMA Guideline on computerized systems and electronic data in clinical trials;
5. Good attention to details;
6. Work well under pressure;
7. Excellent communication, organizational, planning and interpersonal skills;
8. Able to operate independently with minimal supervision;
9. Fluent in English, both written and oral.
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