QC Support Compliance Senior Engineer
QC Support Compliance Senior Engineer
Jobdescription
As a pivotal member of the organization, you will play a crucial role within a diverse team operating in a dynamic, global environment. Your responsibilities will include:
- Acting as the primary compliance representative for the quality control department and QC Support Team
- Taking the lead on deviations, CAPA, and periodic reviews associated with our activities
- Providing expert training in CCP, CAPA, and investigations
- Ensuring and overseeing compliance for the QC Support Group and the Quality Control Department
- Contributing significantly to the continuous improvement of quality control support processes and procedures
- Reviewing and approving internal documents and agreements
- Participating in equipment and material qualification processes
- Serving as a quality project manager to proactively identify and resolve issues
- Collaborating extensively with various functions and stakeholders
- Acting as an expert for deviation, change control, and CAPA topics during health authority inspections
- Providing backup for other QC support compliance, autonomously resolving compliance issues promptly, contributing to continuous improvement using a lean process mindset, and actively participating in performance management meetings to drive improvement.
- Engineering degree in sciences (chemistry, biology) or a minimum of 3 years of experience in a GMP environment
- Minimum of 1 year expertise in the biotech industry
- Highly precise, rigorous, and detail-oriented
- Exceptional team player with the ability to collaborate effectively across departments
- Extensive experience in quality control and quality systems
- Proficiency in planning tools is a plus
- Good knowledge of visual management
- Familiarity with applicable cGMPs
- Fluency in French and English
- Process-oriented with a strong customer service focus
- Proficient in problem-solving tools and ensuring their use in the group
- Results-driven with a "can do" attitude
- Autonomous, reliable, and highly motivated
- Positive and collaborative communication within the team and with partners/customers
Mélissa Peer
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