Responsable Qualification / Validation H/f

Lfb Usa

Alès, France
Hybrid (up to 2 days remote per week after 4 months)
Qualification and validation policy
Validation master plan
Gmp compliance
Lfb USA is seeking a Responsable Qualification / Validation in Alès, France, to oversee the implementation of qualification and validation policies ensuring compliance with regulatory standards in the pharmaceutical sector. The role requires a minimum of four years of relevant experience, particularly in pharmaceutical or biotechnology industries

Job Summary

  • Define and implement the Qualification and Validation policy within LFB to ensure compliance with GMP and regulations.
  • Establish and manage the Validation Master Plan and associated annual programs, including budgets and resources.
  • Ensure equipment, systems, utilities, and premises are qualified and maintained in a validated state, providing documented proof.

Matching Summary

Match Score: 85

Lfb USA is seeking a Responsable Qualification / Validation in Alès, France, to oversee the implementation of qualification and validation policies ensuring compliance with regulatory standards in the pharmaceutical sector. The role requires a minimum of four years of relevant experience, particularly in pharmaceutical or biotechnology industries.

Skills & Requirements

Must-have

  • Qualification and Validation Policy
  • Validation Master Plan
  • GMP compliance
  • Process Validation
  • Computerized Systems Validation

Nice-to-have

  • Complex and critical subjects expertise
  • Root cause analysis
  • Investment project compliance

Key Requirements

  • Engineer or Pharmacist degree
  • Minimum 4 years of experience in the industry
  • Experience in pharmaceutical/biotechnology sector
  • Knowledge of pharmaceutical industrial processes and GMP
  • Experience in writing protocols and reports
  • Skills in equipment, computerized systems, premises, utilities, and environment qualification
  • Experience in equipment validation (CTA, Tank, HVAC)

Work Rights

Not specified

Tailored Resume

Cover Letter