
Data Validation Specialist
3 days ago
We are seeking a highly skilled Data Validation Specialist to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry.
This individual will be responsible for developing comprehensive and regulatory-compliant documentation for data validation processes.
The ideal candidate will be proficient in stakeholder management, user story writing, and technical documentation including validation plans, security plans, VSRs, SOPs, change management, and CAPA.
Required Skills and Qualifications
Key Responsibilities:
- Develop comprehensive and regulatory-compliant documentation for data validation processes.
- Translate complex technical concepts into clear, accessible language for diverse stakeholders.
- Apply industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards.
Qualifications:
- Bachelor's degree in computer science, Life Sciences, or related field (Master's preferred).
- Minimum 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain.
- Strong understanding of data validation principles, GAMP guidelines, and regulatory frameworks.
Benefits
The selected candidate will have the opportunity to work with cross-functional teams to gather inputs and feedback.
They will also be responsible for drafting precise and actionable user stories reflecting functional and compliance requirements.
In addition, they will create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs, and document change control processes and prepare CAPA reports.
Others
The ideal candidate should possess excellent writing, editing, and stakeholder engagement skills.
Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms is also an asset.
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