Data Validation Specialist
6 days ago
Azzur Group is a leading life science company committed to ensuring operational excellence and compliance in the pharmaceutical and biotechnology sectors. We are seeking an experienced Data Validation Specialist to join our growing team.
Key Responsibilities:
- Develop and execute validation documentation, including protocols and reports, for computerized systems in compliance with industry regulations.
- Collaborate with cross-functional teams to assess system requirements and ensure they meet GxP, GDP, GAMP, and 21 CFR Part 11 standards.
- Conduct risk assessments and create strategies to mitigate potential non-compliance risks.
- Perform hands-on testing and create validation testing scripts to confirm system functionality.
- Maintain documentation integrity and manage change controls effectively.
- Communicate project status, issues, and solutions to stakeholders professionally and clearly.
- Provide guidance and training on validation processes and best practices within the organization.
- Stay current with industry regulations and technologies to drive continuous improvement in validation practices.
Requirements
Qualifications:
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
- A minimum of 5-8 years of experience in Computer Systems Validation (CSV) within the pharmaceutical, biotech, or healthcare industries.
- Strong understanding of validation principles and regulatory requirements, including 21 CFR Part 11 and GxP.
- Proficiency in writing and reviewing validation documentation.
- Excellent analytical skills with a keen eye for detail.
- Strong problem-solving abilities and effective communication skills.
- Ability to work collaboratively in a team environment and manage multiple projects simultaneously.
- Relevant certifications, such as Certified Software Quality Engineer (CSQE), are a plus.
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience.
Azzur Group offers a comprehensive benefits package, including health insurance, retirement plans, and paid time off.
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