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2 days ago
Job Title: CSV Specialist
About the RoleWe are seeking a highly skilled and detail-oriented specialist to develop, execute, and maintain validation protocols and documentation ensuring compliance with regulatory standards.
Main Responsibilities:- Develop Computer System Validation (CSV) protocols and reports in accordance with FDA, EMA, and other regulatory requirements.
- Collaborate with cross-functional teams to deliver high-quality CSV documentation on time.
- Maintain accurate records and validation documentation for all CSV-related activities and projects.
- Provide expert guidance on CSV processes and documentation expectations to internal departments and stakeholders.
- Perform validation executions through remote or on-site visits as per client requirements.
Key Requirements:
- Strong understanding of CSV protocols and regulatory standards.
- Excellent collaboration and communication skills.
- Ability to work independently and manage multiple priorities.
- Proficiency in creating and maintaining technical documentation.
- Familiarity with industry regulations and best practices.
Benefits:
- Opportunity to work on challenging projects and contribute to company growth.
- Professional development and training opportunities.
- Collaborative and dynamic work environment.
What We Offer:
- A competitive compensation package.
- Opportunities for career advancement.
- A positive and supportive work culture.
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