Computer Systems Validation Specialist

1 week ago


SaintAubinsurGaillon, Normandie, United States Softworld Inc Full time

Job Title: Computer Systems Validation

Job Summary:

Softworld Inc is seeking a skilled Computer Systems Validation Specialist to support data integrity evaluation, computer system validation, and spreadsheet validation for our clients in the pharmaceutical industry.

Key Responsibilities:

  • Evaluate computerized systems for data integrity risks and develop plans to mitigate those risks or close gaps.
  • Assist system owners with the generation of User Requirement Specifications (URS) related to computerized systems or spreadsheets.
  • Generate computer system validation protocols for computerized systems or spreadsheets.
  • Execute protocols for the validation of computerized systems or spreadsheets in line with FDA and EMEA regulations.
  • Complete reports for the validation of computerized systems and spreadsheets.
  • Owner of actions related to Corrective and Preventive Actions (CAPA) or Change Controls for the update or implementation of computerized systems or spreadsheets.

Requirements:

  • Three (3) years of experience in the validation of computerized systems and spreadsheets.
  • Previous experience in the development and qualification of spreadsheets utilized in a GMP industry (FDA or EMEA).
  • Ability to document activities in line with Good Documentation Practices (GDP).
  • Previous experience in drafting and executing computer system validation documents.
  • Previous experience in writing summary reports for validation activities.
  • Strong knowledge of data integrity principles related to the FDA, MHRA, and EMEA guidelines.
  • Experience in drafting URS documents based upon the input of the owner and stakeholders.
  • Ability to work on multiple projects and prioritize based upon company objectives.

Company Information:

Softworld Inc is a leading provider of IT services and solutions. We are committed to delivering high-quality services to our clients and are seeking a skilled Computer Systems Validation Specialist to join our team.



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