Technicien Assurance Qualité du Contrôle Qualité / QA over QC Associate – All genders
Apply locations Toulouse
Job type: Full time
Posted on: Posted 30+ Days Ago
Job requisition id: JOB ID-11640
General Summary
Dans le cadre du démarrage et de l’exploitation d’une usine de production biotechnologique, Just-Evotec Biologics recherche un technicien qualité sur les activités du contrôle qualité.
Vous rejoindrez une équipe en pleine expansion, multidisciplinaire et collaborative. Sous l’autorité du responsable Assurance Qualité Contrôle Qualité (AQ-CQ) au sein du groupe Assurance Qualité Process, vous assurerez la conformité des activités des laboratoires de contrôle qualité (physico-chimie, microbiologie, biologie cellulaire et moléculaire, stabilité, etc.).
Vous évoluerez dans un cadre règlementé par les Bonnes Pratiques de Fabrication sur notre site de Toulouse.
Just-Evotec Biologics is looking for a quality technician on quality control activities, as part of the start-up and operation of a biotechnology production plant.
You will be joining a fast-growing, multidisciplinary and collaborative team. Reporting to the Quality Assurance-Quality Control (QA-QC) Manager within the Process Quality Assurance group, you will ensure compliance of QC laboratory activities (physico-chemistry, microbiology, and cell & molecular biology, stability etc.).
You will work within a framework governed by Good Manufacturing Practices at our site in Toulouse.
Responsibilities and missions
As such, you will be required to:
* Verify compliance of all data generated by quality control laboratories within the specified deadlines.
* Generate and reconcile the documentation necessary for activities.
* Collaborate closely with the QC team to review/verify documentation related to quality control.
* Handle quality events (deviations, OOS, CAPA, and Change Control).
* Work closely with the QA process team.
* Maintain quality documentation related to activities as a writer, verifier, or approver.
* Participate in recurrence and trend analysis related to QC activities; keep performance indicators up to date.
* Promote a culture of quality, compliance, and continuous improvement within the QA-QC team.
* Participate in ensuring the integrity of laboratory data throughout its lifecycle and assess the impact of incidents (ALCOA+).
* Report within your scope to your supervisor.
* You may also be involved in activities such as regulatory monitoring (Pharmacopoeias), inspections (FDA, ANSM), internal audits, or self-inspections, in collaboration with key managers.
Knowledge, skills, and abilities
* Recognized for interpersonal skills, listening skills, and team spirit. Motivated, enthusiastic, and enjoy challenges.
* Excellent analytical, organizational, and summarizing skills with adaptability.
* Proficient in English (reading and writing) to understand and produce documents.
Experience and education
* Bachelor’s degree (Bac + 2) with specialization in quality assurance.
* Ideally, some successful experience in the pharmaceutical industry.
* Good knowledge of Good Manufacturing Practices.
* Training or experience with ERP and LIMS systems is a plus.
Other information
Permanent contract (CDI).
FR: Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG: In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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