CSV Validation Specialist

2 days ago


Singapur, Singapore Amaris Consulting Full time
Job Title: CSV Engineer

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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