Job type: Durée déterminée

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We are hiring a Custom Field Verification and Excel Spreadsheet Validation Specialist, within an international pharmaceutical industry, the position is a contractor role for 12 months.

Main purpose of the role:

As a Specialist, You will be part of the Technical Support Team of the QC department.

You will be in charge of writing and executing custom field verification and Excel spreadsheet validation protocols.

You will interact with Quality Control, Quality Assurance eSystems, IT and Validation teams.


Responsibilities:

  • Write and execute custom field verification protocols for Empower 3 and Tiamo software
  • Write specification documents (URS, FS/DS, …) for Excel spreadsheets.
  • Create Excel spreadsheet which reflects business needs.
  • Review and approve Excel spreadsheet validation protocols.
  • Provide first line contact with validation and QA e-Systems for the verification/validation protocols.
  • Leads or supports investigations in case of deviations related to custom field verification or Excel spreadsheet validation.
  • Assists with errors and solve problems with minimum guidance; performs simple data fixes.
  • Performs all activities in compliance to cGMP requirements and applicable standards and procedures.

Profile:

  • CFC as Laboratory Technician or BS degree in Science, Computer Science or a related field.
  • A minimum of 2 years of relevant work experience in a GMP regulated environment (or equivalent). Previous experience in a GMP QC role a plus.
  • General computer Literacy (Microsoft Office).
  • Good knowledge of validation requirements.
  • Professional command of French and English, verbal and written (B2).
  • Good technical writing skills
  • Proven time management skills
  • Strong attention to detail.
  • Proven analytical and problem-solving skills.
  • Ability to work independently and compliantly.
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Deadline: 08-06-2024

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