Durée indéterminée

On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a

Quality Control Specialist – Custom Field Verification

Vos tâches

 

  1. Duties and 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.

Votre profil

  1. Skills/Knowledge Required
  • 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.

 

  1. Definitions and Abbreviations
  2. CFC            Certificat Fédéral de Capacité
  3. EHS           Environment Health and Safety
  4. cGMP         current Good Quality practice
  5. IT                Information Technology
  6. LIMS           Laboratory Information Management System
  7. MDM          Master Data Management
  8. QA             Quality Assurance
  9. QC             Quality Control
  10. URS           User requirement specification
  11. FS/DS        Functional specification/Design specification

Date d'entrée

À convenir


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