
Expert System Validator
11 hours ago
We are seeking a highly skilled System Validation Expert to join our team. The ideal candidate will have a strong background in computer system validation, quality compliance, and regulatory affairs.
- A Bachelor's degree in a related field or equivalent is required.
- The successful candidate will have at least 5 years of hands-on experience in computer system validation/quality compliance in a FDA-regulated industry, with a focus on GxP systems.
- Familiarity with cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 standards is essential.
As a System Validation Expert, you will be responsible for ensuring that our computer systems meet the highest standards of quality and safety. This includes developing and implementing validation protocols, conducting risk assessments, and providing training to colleagues.
Required Skills and Qualifications- Strong knowledge of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience with EDMS (Electronic Document Management system) and test management tools.
- Ability to develop clear, concise, and timely reports, with excellent written and oral communication skills.
- Ability to work on complex projects with general direction and minimal guidance.
What We Offer
Our company offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for system validation, we encourage you to apply for this exciting opportunity.
About Us
Our company is a global leader in the field of system validation. We are committed to delivering high-quality solutions that meet the needs of our clients. We are proud to offer a dynamic and supportive work environment that fosters collaboration and innovation.
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