
Senior Validation Specialist
1 day ago
This role demands strong documentation capabilities, effective communication, and deep exposure to CSV practices. As a skilled professional in this field, you will be responsible for developing comprehensive and regulatory-compliant documentation for CSV processes.
- Develop and maintain technical documentation including validation plans, security plans, VSRs, SOPs.
- Create precise and actionable user stories reflecting functional and compliance requirements.
You will translate complex technical concepts into clear, accessible language for diverse stakeholders, collaborate with cross-functional teams to gather inputs and feedback, and ensure documentation meets GxP and GAMP 5 standards.
Required Skills and 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 CSV principles, GAMP guidelines, and regulatory frameworks.
As a member of our team, you will have the opportunity to work with experienced professionals, expand your knowledge of industry-specific tools and technologies, and contribute to the development of high-quality documentation that meets regulatory requirements.
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