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