
System Validation Expert
2 hours ago
About the Role
We are seeking a skilled Validation Specialist to join our team. In this critical role, you will be responsible for ensuring the validation of computer systems and equipment used in a regulated industry.
The ideal candidate will have extensive experience in computer system validation, quality compliance, and regulatory requirements. They will also possess excellent communication skills and the ability to work effectively in a fast-paced environment.
Key Responsibilities:
- Developing and implementing validation strategies for computer systems and equipment.
- Conducting risk assessments and recommending control measures to mitigate risks.
- Coordinating with cross-functional teams to ensure compliance with regulatory requirements.
- Providing training and support to colleagues on validation procedures and best practices.
Requirements
- 5-8 years of hands-on experience in computer system validation and quality compliance in a regulated industry.
- Strong knowledge of GxP system fundamentals and FDA/EMA regulations.
- Hands-on experience with EDMS and test management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
Benefits
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A collaborative and dynamic work environment.
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