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Quality Assurance System Specialist

Il y a 2 mois


Toulouse, Occitanie, France Flash Therapeutics Temps plein

Quality Assurance System Specialist

We are seeking a dedicated and enthusiastic Quality Assurance System Specialist to enhance our innovative team. Your primary responsibility will be to ensure that our quality management system adheres to regulatory standards while preparing the organization for GMP inspections (Good Manufacturing Practices). Additionally, you will play a crucial role in overseeing the quality assurance processes for our suppliers and subcontractors.

Key Responsibilities:

1. Management of Quality Systems:

  • Develop and continuously refine the quality management system.
  • Draft, update, and authorize quality documentation.
  • Oversee deviation management, CAPA (Corrective and Preventive Actions), change control, and customer feedback processes.
  • Establish and monitor internal audit schedules.
  • Ensure the quality assurance of computerized systems in collaboration with external partners and internal stakeholders.
  • Track and analyze sector performance metrics.

2. Readiness for Inspections:

  • Organize and facilitate activities related to client inspections and audits.
  • Maintain site readiness for inspections at all times.
  • Provide ongoing training for staff on GMP standards and internal quality protocols.

3. Quality Assurance for Suppliers and Subcontractors:

  • Assess and qualify suppliers and subcontractors in accordance with GMP standards.
  • Conduct quality audits of suppliers and subcontractors to ensure adherence to GMP requirements.
  • Manage follow-up on subcontracted analyses (contracts/schedules/results management/OOS).

Ideal Candidate Profile:

  • Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline.
  • At least 3 years of experience in a comparable role within a GMP-regulated setting.
  • Comprehensive understanding of GMP standards.
  • Strong communication and problem-solving abilities.
  • Capacity to work autonomously as well as collaboratively within a team.
  • Proficient in professional English.
  • In addition to technical expertise, we value a candidate with a positive attitude and the ability to collaborate effectively in a demanding environment.