
Data Validation Specialist
1 day ago
We are seeking a highly skilled and detail-oriented professional to lead our data validation initiatives.
The ideal candidate will be responsible for developing, executing, and maintaining comprehensive validation protocols and documentation to ensure regulatory compliance.
Key responsibilities include:
- Designing and implementing data validation strategies in accordance with FDA, EMA, and other regulatory requirements.
- Collaborating with cross-functional teams to deliver high-quality validation documentation on time.
- Creating user manuals, SOPs, and technical documentation related to data validation processes.
- Executing data validation activities, including risk assessments, testing, and documentation reviews.
- Supporting audits and inspections by providing relevant documentation and participating in audit response efforts.
- Staying up-to-date with industry regulations and ensuring company practices align with current best practices.
- Training internal teams and stakeholders on data validation processes and expectations.
- Driving continuous improvement efforts to enhance data validation processes and document efficiency.
- Maintaining accurate records and validation documentation for all data-related activities and projects.
- Bachelor's degree in Computer Science, Engineering, or a related field.
- Proven experience in data validation within regulated industries.
- Strong understanding of GxP compliance, FDA, EMA guidelines, and related industry standards.
- Exceptional communication skills with the ability to produce clear, concise, and structured documentation.
- Detail-oriented, with excellent analytical and problem-solving skills.
- Capable of working independently as well as collaboratively in a team environment.
- Flexibility to travel for client visits or perform remote validation execution as needed.
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