
Validation Specialist
1 week ago
This role involves ensuring the quality and regulatory compliance of processes at a critical level.
- Develop comprehensive documentation for validation processes.
- Translate complex technical concepts into clear language.
- Apply industry-specific knowledge to ensure documentation meets regulatory standards.
- Collaborate with cross-functional teams to gather inputs and feedback.
- Draft user stories reflecting functional and compliance requirements.
- Create and maintain technical documentation including validation plans, security plans, VSRs, SOPs.
- Document change control processes and prepare CAPA reports.
To excel in this role, you should have:
- Bachelor's degree in computer science or related field (Master's preferred).
- Minimum 5+ years of experience as a technical writer in the pharmaceutical domain.
- Strong understanding of validation principles, GAMP guidelines, and regulatory frameworks.
- Excellent writing, editing, and stakeholder engagement skills.
- Knowledge of data integration and analysis, and familiarity with Azure Databricks platforms.
This is an excellent opportunity to leverage your expertise in CSV principles and GAMP guidelines to drive quality and regulatory compliance within a dynamic organization.
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