
Senior Data Validation Specialist
4 days ago
Job Description:
We are seeking a highly skilled Senior Data Validation Specialist to join our growing operations in Brisbane. The successful candidate will be responsible for developing and executing protocols and test scripts, identifying gaps, and consulting on and directing plans for resolution.
- Main Responsibilities:
- Develop and execute protocols and test scripts
- Identify gaps and consult on and direct plans for resolution
- Write computer validation and regulatory documentation
- Manage change controls and other compliance-related tasks
- Analyse the results of testing and determine acceptability of results against predetermined criteria
- Investigate and troubleshoot problems and determine solutions or recommendations for changes and/or improvements
- Coordinate with other departments or outside contractors/vendors to complete validation tasks
Required Skills and Qualifications:
- Bachelor's degree in Computer Science or Engineering field or equivalent experience
- Minimum 2-7 years' experience with Computer Systems Validation
- Minimum 2-7 years' experience working in a GMP environment
- Experience in Data Integrity with GAMP and 483 compliance, deep regulatory knowledge desired
- Experience in biotech and pharma preferred over medical device
- Experience with MES, Delta V, PI is a plus
Benefits:
- Highly competitive salary
- Continuing education (internal and external)
- Opportunities to work on cutting-edge projects in a highly evolving field
About Our Company:
We are a global company committed to living our Foundational Principles, both professionally and personally: acting with integrity, serving each other, serving society, and working for our future. As an employee-owned company, we are dedicated to providing excellent services and opportunities for growth and development.
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