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Reporting to the Site Quality Manager, you will be responsible for approving and monitoring the quality of suppliers in accordance with the most stringent pharmaceutical requirements, thereby ensuring the quality of purchased or subcontracted products.
Job Responsibility:
Ensure relationships with suppliers and subcontractors
Participate in the approval, evaluation and monitoring of suppliers
Conduct supplier audits and monitor action plans
Conducting and monitoring supplier and subcontractor complaints
Assist subcontractors in the commissioning and monitoring of new production processes
Create and manage supplier documents and areas related to incoming quality
Occasional travel in France and abroad
Suggest actions for improvement and problem solving
Participate in product/process risk analysis with suppliers and subcontractors
Implementing and monitoring corrective and preventive actions
Participate in the preparation of documents related to the QHSE system
Monitor and participate in qualification and change control processes
Assist with awareness raising and training of staff and suppliers
Ensure that standards and procedures are applied internally
Participate in the drafting/modification of internal procedures and documents related to changes in the company or regulations
Carry out internal audits
Bring any anomalies or difficulties to the attention of the line manager as soon as possible
Requirements:
BAC +3 or equivalent in Quality
English: ability to deal with a wide range of subjects
Knowledge of ISO 13485 and ISO 15378 standards and medical device regulations an advantage
Organised, rigorous and methodical
Ability to work independently
Respect for deadlines
Discretion
Good writing skills – Good interpersonal skills
Adaptability to different situations
Nice to have:
Knowledge of ISO 13485 and ISO 15378 standards and medical device regulations an advantage
What we offer:
The opportunity to work from home with executive status
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