
Senior Validation Specialist
3 days ago
We are seeking a skilled and detail-oriented professional to join our organization in the capacity of Senior Validation Specialist. This position requires strong technical knowledge, effective communication skills, and a deep understanding of regulatory requirements.
Key Responsibilities:
• Develop comprehensive documentation for validation processes.
• Translate complex technical concepts into clear language for diverse stakeholders.
• Ensure documentation meets GxP and GAMP 5 standards.
• Collaborate with cross-functional teams to gather inputs and feedback.
• Draft precise user stories reflecting functional and compliance requirements.
• Create and maintain technical documentation including validation plans, security plans, and change control processes.
Qualifications:
• Bachelor's degree in a relevant field (Master's preferred).
• Minimum 5+ years of experience as a technical specialist in the pharmaceutical or life sciences domain.
• Strong understanding of validation principles, GAMP guidelines, and regulatory frameworks.
• Excellent technical writing, editing, and stakeholder engagement skills.
• Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.
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