
Pharmaceutical Documentation Specialist
1 day ago
We are seeking a highly skilled and detail-oriented technical writer to create comprehensive and regulatory-compliant documentation for CSV 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: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.
- Excellent writing, editing, and stakeholder engagement skills.
- Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.
The successful candidate will have the opportunity to work on challenging projects, develop their skills, and contribute to the growth and success of our organization.
Others:As a pharmaceutical documentation specialist, you will be responsible for creating high-quality documents that meet regulatory requirements. You will work closely with cross-functional teams to gather inputs and feedback and ensure that all documentation is accurate, complete, and compliant with industry standards.
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