CSV Validation Specialist
2 days ago
Amaris Consulting is seeking a skilled CSV Engineer to join our team.
Key Responsibilities:
- Validation Planning: Develop and implement CSV strategy and validation plans for computerized systems, including Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Electronic Batch Records (eBR), and other relevant software.
- Validation Documentation: Create and review validation documentation, including validation protocols, test scripts, and traceability matrices.
- Testing and Execution: Execute validation protocols and test scripts, documenting test results, deviations, and issues. Perform functional testing, security testing, and data integrity checks.
- Change Control and Documentation: Implement and manage change control processes for computerized systems, including assessing the impact of changes on validated systems.
- Data Integrity: Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
Qualifications:
- Bachelor's degree in computer science, engineering, pharmaceutical sciences, or a related field.
- Strong knowledge of pharmaceutical regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and quality standards (GMP, GLP).
- Experience in computer systems validation within the pharmaceutical industry.
- Proficiency in validation tools, methodologies, and validation testing techniques.
- Familiarity with software development life cycle (SDLC) processes and methodologies.
- Excellent project management skills and attention to detail.
- Effective communication and collaboration skills.
- Knowledge of data integrity principles and security best practices.
- Experience with regulatory audits and inspections is a plus.
Amaris Consulting is an equal-opportunity workplace committed to promoting diversity and creating an inclusive working environment. We welcome applications from all qualified candidates.
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