Responsable Qualification / Validation H/f

Groupe Lfb

Alès, France
Hybrid (up to 2 days remote after 4 months)
Qualification and validation policy
Validation master plan
Gmp compliance
Groupe LFB is seeking a Responsable Qualification / Validation in Alès, France, to oversee the qualification and validation policy within the company. The ideal candidate should have a background in engineering or pharmacy, with at least four years of relevant experience in the pharmaceutical or biotechnology industry

Job Summary

  • Define and implement the Qualification and Validation policy to ensure equipment, facilities, utilities, computerized systems, processes, and analytical methods are validated and maintained in a validated state in compliance with GMP and current regulations.
  • Establish and pilot the Validation Master Plan (VMP) for sites and associated annual programs, manage budgets and resources for Qualification/Validation activities, and ensure timely availability of compliant equipment.
  • This position offers a permanent contract (CDI) with group benefits including health insurance, provident fund, works council, savings plan, profit-sharing bonus, and meal vouchers, with a teleworking agreement allowing up to 2 days per week after 4 months of seniority.

Matching Summary

Match Score: 85

Groupe LFB is seeking a Responsable Qualification / Validation in Alès, France, to oversee the qualification and validation policy within the company. The ideal candidate should have a background in engineering or pharmacy, with at least four years of relevant experience in the pharmaceutical or biotechnology industry.

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
  • Investment project compliance

Key Requirements

  • Engineer or Pharmacist degree
  • Minimum 4 years of experience in the industry
  • Experience in health sector (pharma, biotech)
  • Knowledge of pharmaceutical industrial processes and GMP
  • Protocol and report writing skills
  • Equipment, computerized systems, facilities, utilities, and environment qualification skills
  • Equipment validation (CTA, Tank, HVAC)

Work Rights

Not specified

Tailored Resume

Cover Letter