We are looking for a Quality Assurance Manager (QAM) that will play a crucial role in ensuring the quality and effectiveness of processes within an organization.
Responsibilities:
- Knowledge of GMP (Good Manufacturing Practices): The QAM must be well-versed in industry regulations and guidelines related to quality standards.
- Collaboration with HQU (Head of Quality Unit): The QAM works closely with the Head of Quality Unit to provide consistent and efficient oversight within their area of responsibility.
- Comprehensive Documentation System: The QAM defines and manages an exhaustive documentation system for all operations related to the Cell Factory.
- Approval of Procedures: The QAM approves all procedures applicable to the Cell Factory, ensuring alignment with established standards (such as G-QA-SOP-0001).
- Risk Analysis Implementation: The QAM establishes and implements a risk analysis system to identify and mitigate potential risks.
- Change Management System: The QAM develops and enforces a system for managing changes effectively.
- Deviations and Corrective Actions: The QAM defines and implements processes for handling deviations and corrective/preventive actions.
- Annual Quality Review: Regularly evaluating achieved results through the Annual Quality Review.
- Product Quality Review: Periodically assessing product quality and process efficiency through the Product Quality Review.
- Compliance Inspections: Regularly inspecting all departments to assess compliance with cGMP (current Good Manufacturing Practices) standards.
- New Project Competence: Managing aspects related to the introduction of new projects.
- Training Plans: Developing appropriate training plans for newly hired or existing personnel.
- Batch Record Distribution: Distributing production Batch Records.
- Batch Record Review: Conducting thorough reviews of Batch Records.
- Deviations and Out-of-Spec Results: Ensuring timely management and proper investigation/documentation of deviations and out-of-specification results.
- Supplier Qualification and Audits: Qualifying external suppliers and conducting necessary audits.
- Complaint Handling: Managing customer complaints effectively.
- Validation Activities: Defining activities to be subjected to validation.
- Validation Outcome Verification: Verifying the outcomes of validations.
- Process Validation Maintenance: Ensuring the process validation status is achieved and maintained.
- Tool Qualification Verification: Verifying reports related to equipment qualification.
The QAM’s role is critical in maintaining high-quality standards and continuous improvement within the organization.
Sterility assurance skills is a nice to have
The QA Sterility Assurance role requires a strong knowledge of microbiology, safety testing, environmental monitoring, Clean Room qualification and management, and microbiological control strategies. The role also demands specific skills in aseptic production techniques, along with general knowledge of quality assurance and GMP regulations.
- Manage a comprehensive documentation system for all operations within the scope of the Cell Factory
- Define and implement a risk analysis system to evaluate and control all aspects of sterility assurance for products and processes
- Ensure the adequate definition of production and quality control activities for microbiological contamination control
- Review existing procedures to ensure GMP regarding material handling and transfer, operator training, sterile dressing, cleaning practices, aseptic practices, aseptic process simulations, behavior in classified areas, environmental monitoring, and microbial control
- Define the strategy and action plan for microbiological validation activities
- Lead the design, review, and update of contamination control strategies
- Ensure that the aseptic process validation status is achieved and maintained
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.
Report job
