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LFB

Public health biopharmaceuticals via plasma-derived products

Chargé Qualification / Validation

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLes Ulis, FranceNo salary listed

About the Job

Requirements

  • A degree in engineering or Bac+5 in chemistry, biochemistry, microbiology, pharmaceutical studies, or quality.
  • At least three years of experience in a similar qualification/validation position in a pharmaceutical environment.
  • Adaptability in managing change and unexpected situations; analytical and synthesis skills; autonomy, leadership, rigor, responsiveness, conscientiousness, inter-service and inter-department communication, and collaborative work.
  • Knowledge of the V-cycle, ActiveFactory/Inbatch, and Trackwise.

Responsibilities

  • Write protocols and reports according to procedures and ensure compliant equipment within the assigned scope is available on time.
  • Review and correct service-provider protocols and reports in support of the activity.
  • Write periodic reviews and periodic qualification protocols and reports defined in the site's Validation Program.
  • Participate in establishing procedures for the service.
  • Contribute to evaluating the impact of changes on validated or qualified status and on processes in operation or in project, including processing DCI.
  • Support service providers in carrying out qualification and validation exercises.
  • Analyze non-conformities and deviations and assess their impacts.
  • Participate in cross-functional working groups and propose solutions to ensure a consistent approach and meet department objectives.
  • Participate in validation activity planning with multidisciplinary teams, including control laboratories, production, and quality assurance.
  • Propose improvements to the role's activities and/or the service's activities.
  • Report activities to the Deputy Qualification/Validation Manager for the specialty.
  • Monitor and maintain a field presence during production testing in controlled-atmosphere zones (ZAC).

Desired Qualifications

  • Training in Good Manufacturing Practices (GMP), fluent English, and knowledge of pharmaceutical regulations are an advantage.

About the Company

LFB

Public health biopharmaceuticals via plasma-derived products

LFB develops and manufactures medicines from plasma and biotechnological products. It collects plasma, fractionates it to produce plasma-derived medicines, and develops recombinant proteins to treat rare diseases. Its distinction comes from its origins as a state-led public health mission that became a publicly owned company with the French State as sole shareholder, plus vertical integration (including EUROPLASMA) and sustained capital investments to secure its supply chain. Its goal is to ensure a reliable supply of essential medicines for public health while growing as a global biopharmaceutical company.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Courcebœufs, France
Founded
1994

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