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Quality Assurance Specialist
Il y a 3 mois
START: ASAP
UTILISATION: 40 HOURS
CONTRACT LENGTH: 9 MONTHS
LANGUAGE REQUIREMENTS: FLUENT FRENCH AND ENGLISH
TIME ON SITE: 100%
Key Responsibilities:As a vital member of the Quality Department, reporting directly to the Deputy Operational Quality Assurance Manager, you will be entrusted with a variety of essential tasks:
- Engage in the deviation management process, assessing and authorizing deviations.
- Contribute to the formulation of CAPA action plans and secure their endorsement.
- Assist in the organization of technical shutdowns, oversee operations, and authorize the resumption of production when necessary.
- Participate in working groups and cross-functional projects.
- Review and approve documentation associated with various Quality Systems relevant to operational activities.
- Involve in the industrial change process, coordinating efforts as needed.
- Support and/or execute the operational quality segment of Product Quality Reviews.
- Help develop quality assurance tools, including procedures, checklists, informational materials, and performance indicators.
- Verify and sanction qualification and validation protocols and reports related to workshop operations.
- Engage in internal and external audits, self-inspections, and regulatory inspections.
- Maintain a consistent presence in the field.
- Conduct training sessions.
- Prepare and verify documentation by production batch.
- Ensure the completeness of traceability and status of plasma intermediate product batches in both physical and digital records, archiving them in compliance with regulations.
- Make informed decisions regarding the acceptance or rejection of products based on patient safety and quality considerations impacting downstream processes.
