QC Support Compliance Engineer
job details
As a key member of the organization, you'll be part of a diverse team in a dynamic, global environment. Your role involves:
- Serving as a compliance representative for the quality control department and QC Support Team
- Leading deviations, CAPA, and periodic reviews related to our activities
- Providing training in CCP, CAPA, and investigations
- Ensuring compliance for the QC support Group and the Quality Control Department
- Contributing to the continuous improvement of quality control support processes and procedures
- Reviewing and approving internal documents and agreements
- Participating in equipment and material qualification
- Acting as a quality project manager to proactively identify and resolve problems
- Collaborating with various functions and stakeholders
- Serving as an expert for deviation, change control, and CAPA topics during health authority inspections
- Backup for other QC support compliance, autonomously resolve compliance issues promptly, contribute to continuous improvement using a lean process mindset, and actively participate in performance management meetings to drive improvement.
As a key member of the organization, you'll be part of a diverse team in a dynamic, global environment. Your role involves:
- Serving as a compliance representative for the quality control department and QC Support Team
- Leading deviations, CAPA, and periodic reviews related to our activities
- Providing training in CCP, CAPA, and investigations
- Ensuring compliance for the QC support Group and the Quality Control Department
- Contributing to the continuous improvement of quality control support processes and procedures
- Reviewing and approving internal documents and agreements
- Participating in equipment and material qualification
- Acting as a quality project manager to proactively identify and resolve problems
- Collaborating with various functions and stakeholders
- Serving as an expert for deviation, change control, and CAPA topics during health authority inspections
- Backup for other QC support compliance, autonomously resolve compliance issues promptly, contribute to continuous improvement using a lean process mindset, and actively participate in performance management meetings to drive improvement.
- qualifications
- Eng. in sciences (chemistry, biology) or 3+ years of experience in a GMP environment
- Minimum 1 year expertise in the biotech industry
- Precise, rigorous, and detail-oriented
- Team player with the ability to collaborate across departments
- Experience in quality control and quality systems
- Experience in planning tools is a plus
- Good knowledge of visual management
- Familiar with applicable cGMPs
- Fluent in French and English
- Process-oriented with a strong customer service focus
- Proficient in problem-solving tools and ensuring their use in the group
- Result-driven with a "can do" attitude
- Autonomous, reliable, and highly motivated
- Positive and collaborative communication within the team and with partners/customers
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