
Senior Computer System Validation Specialist
6 days ago
We are looking for a skilled Validation Engineer to join our team.
The ideal candidate will have hands-on experience in computer system validation strategies to ensure compliance with FDA regulations.
Key responsibilities include:
- Developing and implementing computer system validation strategies.
- Conducting risk assessments and gap analyses.
- Collaborating with cross-functional teams to develop quality assurance procedures.
The candidate should also have knowledge of fundamental GxP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
Requirements for the role include:
- 5-8 years of experience in computer system validation.
- Strong understanding of FDA's recent guidance on transition of CSV to CSA.
- Excellent written and oral communication skills.
- Ability to work on complex projects with minimal guidance.
This is an excellent opportunity for a motivated individual to make a real impact in the field of computer system validation.
What We OfferA challenging and rewarding role in a dynamic industry, with opportunities for professional growth and development.
A collaborative and supportive team environment.
A competitive salary and benefits package.
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