For one of our client based in Fribourg Canton, we're looking for a
- Manage all the activities of the product lines.
- Deviation/Change management
- Approval of area SOPs/Batch documentation
- Reviewing & Approving corrective and preventive actions system.
- Helps with the deployment of GMP culture.
- Responsible for ensuring that manufacturing practices and operations do not affect the efficacy and safety of the products.
- Handles deviation investigation process.
- Performs and reviews product impact assessments and investigations to ensure root cause analysis, timely resolution and, if deemed necessary, the appropriate CAPAs initiation.
- Responsible for escalating significant deviations for appropriate regulatory action if necessary and for performing trending for identifying potential causes of recurring or severe non conformites.
- Evaluates and performs impact assessment of changes, handles the change control.
- Oversees the creation/revision and approval of QA-owned SOPs, Work Instructions, Forms or other supporting documents.
- Optimizes department procedures to improve efficiency.
- Perform Quality inspections and batch record reviews.
- Responsible for QA product reviewing and approval of production SOPs/Batch documentation.
- Interacts with regulatory and partner auditors/inspectors
- Experience in a biotechnology GMP environnement, ideally in diagnostic quality or technical area.
- Your Mother tongue is French and/or German
- Your English is fluent (oral and written)
- You have a minimum of 4 years of pharmaceutical/biological manufacturing and/or QC/QA related experience. In dephth knowledge of Biologic and Device manufacturing, GMPs, associated guidelines, ISO requirements and related regulations.
- Ability to quickly and logically evaluate and solve problems on a daily basis, and guide others to do the same.
- Ability to make sound decisions and correctly evaluate decisions of others.
- You have strong scientific analytical skills
- You must be able to think abstactly about data and be able to work with a team toward shared goals
- You must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.
If you think your profile is matching, please feel free to apply !