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QA Downstream Manager
Il y a 3 mois
Make your mark for patients
We're in search of a Quality Downstream Manager with excellent communication skills, agile and a readiness to face challenges to join our Quality Department team, based in Braine-l'Alleud, Belgium, and play a pivotal role in our brand new Biomanufacturing plant.
About the Role:
In this vital position, you'll:
Be instrumental in the facility startup, ensuring agility, proactivity, and clear accountability for all quality aspects related to Downstream manufacturing activities. Manage both short-term and long-term Downstream quality oversight, from technology transfers and validations to ensuring compliance with cGMP Regulations. Develop your team, fostering career growth, and build concerted relationships across departments.Who You'll Work With:
Quality Assurance Teams: work closely with Quality Assurance teams to ensure compliance and address quality issues promptly.
Production Teams: Partner with production teams, providing quality oversight and Support for Downstream manufacturing operations.
Compliance Teams: Work alongside compliance teams to ensure all manufacturing activities meet regulatory standards.
Corporate Quality Partners: Build trustful and Collaborative relationships with corporate quality partners, contributing to the overall quality strategy and initiatives.
Key Responsibilities:
Short-term Activities:
Actively participate in Downstream technological transfer teams. Ensure Downstream manufacturing activities' validations are in line with cGMP Regulations. Lead GMP certification inspections for your area. Provide GMP authorization for the start of manufacturing activities after ensuring all prerequisites for critical milestones are met.Medium to Long-term Activities:
Oversee the quality of Downstream manufacturing operations daily. Manage quality for Downstream manufacturing-related activities, including Qualification and Validation, Vendors Change Notification, etc. Conduct efficient and accurate batch review processes and release Process Orders related to Downstream manufacturing activities. Maintain quality systems within your scope, monitor quality performance with relevant KPIs, and promote Quality on the Shop Floor culture. Direct actions in answer to manufacturing incidents affecting quality or compliance, ensuring thorough investigations and adherence to escalation mechanisms. Supervise daily departmental activities, ensuring alignment with Quality assurance peers and fostering a reliable partnership with local and global business partners.Interested? We're looking for someone with:
A master's degree in a relevant field is preferred 5 years or more of experience in the pharmaceutical industry within manufacturing operations, focusing on sterile or biological products, preferably within Downstream manufacturing operations. Deep comprehension of cGMP for biological products. Agility and adaptability in a dynamic environment. Strong communication skills and a team player mindset. Solutions oriented Fluency in English. French is a strong asset.To know more about our biotech activities visit our
#biomanufacturing
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
