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CSV & QA Specialist - France

Digital Links Inc

Delaware State

Role: CSV & QA Specialist

Location: On-site: 4 days per week - Alby Sur Ch ran France

We are looking for an experienced CSV & QA Specialist to support the Digital Factory Program (DFP), a strategic digital transformation initiative aimed at implementing and validating several GxP-critical systems across manufacturing operations.

Key Responsibilities

The Digital Factory Program includes the deployment of:

  • K rber PAS-X MES (Manufacturing Execution System) to manage and execute manufacturing operations.
  • WMS (Warehouse Management System) to optimize warehouse and inventory management processes.
  • AVEVA System Platform for equipment supervision, process integration, and manufacturing recipe management.
  • LIMS update
  • Empower installation
  • Implementation of an Electronic Batch Record (EBR) solution to fully digitalize batch documentation and manufacturing records.

The ultimate objective of the program is to establish a compliant, integrated digital manufacturing ecosystem that enables end-to-end electronic batch record management while ensuring data integrity, traceability, and regulatory compliance.

Candidate Profile

The ideal candidate should meet the following criteria:

  • More than 8 years of experience in Computerized System Validation (CSV) within regulated environments.
  • Demonstrated experience supporting validation projects involving systems such as MES, WMS, or AVEVA System Platform.
  • Strong knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11, and Data Integrity requirements.
  • Excellent English communication skills, both written and verbal, with the ability to work effectively in an international environment.
  • Ability to work independently while collaborating within multidisciplinary project teams.
  • Strong organizational, communication, and stakeholder management skills.
  • Remote work: 1 day per week.
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Vacancy posted 2 days ago
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