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Computer System Validation Expert
3 weeks ago
System Validation Specialist Role
- Maintain high-quality validation standards in regulated industries.
- Develop expertise in GxP system, cGMP concepts, and FDA/EMA regulations.
- Manage multiple projects with minimal supervision.
- Prioritize workflow to meet project deadlines.
Job Requirements:
- Minimum 5-10 years of experience in Computer System Validation.
- Strong knowledge of electronic document management systems and test management tools.
- Excellent written and oral communication skills.
- Able to adapt to changing priorities.
Key Responsibilities:
- Produce timely and accurate reports.
- Lead multiple projects simultaneously.
- Manage workloads effectively.
Education and Skills:
- Hands-on experience in EDMS & Test Management tools.
- Knowledge of FDA's recent guidance on CSV to CSA transition.
- Ability to communicate complex ideas effectively.
- High level of analytical and problem-solving skills.
Additional Information:
- Ability to prioritize tasks effectively.
- Strong understanding of computer and equipment validation processes.
- Ability to maintain confidentiality and professionalism.
