Computer Systems Validation - Data Integrity

Chapel Hill, NC 27703

Posted: 07/09/2024 Employment Type: Contract Industry: IT Job Number: BBBH77442_1720565343 Pay Rate: Up to US$0.00 per year

Job Description

Job Title: Computer Systems Validation - Data Integrity

Job Location: Durham North Carolina 27703

Onsite required

M-F. 8-5, 40hrs/week

Duration: 6 Month+

Onsite Requirements:
  • CSV
  • FDA CFR 21 Part 11
  • Data Integrity

Job Description:
  • The CSV and Data Integrity Contractor will support data integrity evaluation, computer system validation, and spreadsheet validation for client's site in RTP.
  • The role will generate protocols, execute the protocols, and complete reports to close out the protocols.
  • The position will involve working on multiple projects simultaneously and completing the requirements in line with company objectives.
  • The role will be a 4-month contract position.

  • Evaluate computerized systems (including equipment with computerized components) 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. The role will utilize their experience to complete the activities independently with supervision from the CSV and Data Integrity Manager.
  • Execute protocols for the validation of computerized systems or spreadsheets in line with FDA and EMEA regulations. Protocols are to be completed in accordance with Good Documentation Practices (GDP).
  • 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.

  • 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 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.

** This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future. **
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