CMC Quality Solutions Specialist
Brabant Wallon – Contracting
Your responsibilities?
As Quality Solutions Specialist you will provide support to a group of CMC Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development.
- Product Change Control Committee preparation and change controls follow-up
- Maintenance and lifecycle management of QA product flows
- Audits and Inspection anticipation and readiness
- Product metrics
- Review of Annual Stability Plan
- SOPs and other control documents writing, review and approval as needed
- Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
- Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
- Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
- Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
- Product Quality Complaint Committee preparation and complaints oversight
- Product recall and product escalation meeting preparation
- Annual report (i.e., reporting of change controls to Health authorities…)
- Yearly Biological Product Report
Your Profile?
- Minimum of 3 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience in GMP in Quality, Manufacturing or Quality Control would be an asset
- Fluent and confident use of English
- Knowledge in several areas of the global pharmaceuticals industry, including the interpretation and practical application of applicable regulations.
- Autonomy and adaptability
- Skilled and experienced in operating across cultures and in a multi-cultural environment
- Understanding of CMC Regulatory requirements
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
