Cadre Assurance Qualité – Validation des systèmes informatisés

TN France; Toulouse; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An established industry player is seeking a passionate Quality Assurance Specialist to join their dynamic team in Toulouse. This pivotal role involves ensuring that Good Manufacturing Practices are upheld in computerized systems within a biomanufacturing environment. You will collaborate closely with the CSV team, oversee quality during protocol execution, and review critical documentation to ensure compliance. If you are a detail-oriented professional with a strong background in validation and an eagerness to contribute to innovative projects, this opportunity is perfect for you. Join a forward-thinking company that values diversity and inclusion in the workplace.

Qualifications

• 2-3 years of experience in qualification/validation and computerized systems.
• Familiarity with GMP, particularly annexes 11 and 15.

Responsabilités

• Acting as the QA contact for GxP systems and collaborating with the CSV team.
• Reviewing and approving qualification and validation documentation.

Connaissances

GMP Compliance

Analytical Skills

Interpersonal Skills

Organizational Skills

Communication Skills

Formation

Master's Degree

Outils

Laboratory Information Management System (LIMS)

Empower

PAS-X

Veeva

Kepware

Description du poste

Job Description

Just Evotec Biologics EU is seeking a highly motivated Quality Assurance Specialist in Computerized System Validation (F/M/D) to join our team in Toulouse, France. This role requires an EU work permit.

The successful candidate will be part of a project to build a biomanufacturing site, ensuring that Good Manufacturing Practices (GMP) are applied to GxP computerized systems. Responsibilities include:

1. Acting as the Quality Assurance contact for GxP systems, attending meetings, and collaborating closely with the CSV team to advance project goals.
2. Reviewing and approving qualification and validation documentation, ensuring compliance with GMP Parts I and II, and annexes 11 and 15.
3. Providing quality oversight during protocol execution and assisting in discrepancy resolution.

The GxP systems managed may include:

• Laboratory Information Management System (LIMS)
• Empower (Laboratory tool)
• PI and Kepware (Data historian solutions)
• PAS-X (Manufacturing Execution System)
• Veeva (Quality Management System)

Qualifications

• Master's degree or equivalent, with at least 2-3 years of experience in qualification/validation and computerized systems.
• Strong interpersonal, listening, team spirit, and curiosity skills.
• Excellent analytical, organizational, and summarizing skills; adaptable and autonomous.
• Familiarity with one or more of the listed systems as a user.
• Knowledge of Good Manufacturing Practices, particularly annexes 11 and 15, and familiarity with GAMP5.
• Qualification/validation process experience is an asset.
• Fluent in French (written and spoken) and proficient in English (written and spoken) for effective communication.

In accordance with our Diversity policy, Evotec welcomes applications from all qualified individuals, including those with disabilities.