CSV and Data Integrity - Katalyst Healthcares & Life Sciences

• 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.

• The CSV and Data Integrity Contractor will support data integrity evaluation, computer system validation, and spreadsheet validation for the 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 6-month contract position with possible extension.

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 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.