CSV Validation Specialist

2 months ago


Singapore Amaris Consulting Full time

Job Title: CSV Validation Specialist

Job Summary:

Amaris Consulting is seeking a skilled CSV Validation Specialist to join our team. The ideal candidate will have a strong background in computer systems validation within the pharmaceutical industry.

Key Responsibilities:

  • Develop and implement CSV strategy and validation plans for computerized systems.
  • Create and review validation documentation, including validation protocols, test scripts, and traceability matrices.
  • Execute validation protocols and test scripts, documenting test results, deviations, and issues.
  • Implement and manage change control processes for computerized systems.
  • 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 and quality standards.
  • Experience in computer systems validation within the pharmaceutical industry.
  • Proficiency in validation tools, methodologies, and validation testing techniques.
  • Excellent project management skills and attention to detail.
  • Effective communication and collaboration skills.

Amaris Consulting is an equal-opportunity workplace committed to promoting diversity and creating an inclusive working environment.



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