Quality Assurance Specialist
il y a 2 semaines
We are seeking a highly skilled Quality Assurance Specialist to join our team at Ethypharm Group. As a Quality Assurance Specialist, you will be responsible for maintaining our quality assurance system in compliance with ISO 13485 and applicable standards.
Key Responsibilities:- Maintain Sinclair France's quality assurance system in compliance with ISO 13485 and applicable standards.
- Report to the Quality Assurance Manager on the follow-up of actions and activities.
- Manage internal and external documentation and records for the local QMS: staff training, distribution, filing, archiving, etc.
- Recording, analysing and investigating the causes of non-conformity; defining and monitoring the implementation and effectiveness of corrective and preventive actions; managing the associated documentation.
- Compile and assess supplier and subcontractor control elements in collaboration with the Purchasing department; monitor the updating of supplier and subcontractor certificates.
- Participate in handling supplier complaints in collaboration with the Purchasing department.
- Carrying out internal audits; or participating in internal audits carried out by external consultants; monitoring the implementation of associated action plans.
- Creation and updating of raw materials and components specification sheets.
- Checking and releasing raw materials and components.
- Drawing up and checking derogations and reprocessing instructions.
- Placing products under EXTRA CQ or Quarantine status.
- Reviewing batch records and releasing batches of finished products, excluding deviations.
- Participating in the qualification of site quality control equipment.
- Monitor the maintenance and metrology of quality control equipment.
- 2/3 years' higher education in a scientific and/or quality control field.
- 6 months' experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department.
- Good command of IT tools (Word, Excel).
- Intermediate to fluent English (written and spoken).
- At least 1 year's experience in the field of injectable products.
- Fluent English (written and spoken).
We are looking for a highly motivated and organized individual with excellent communication skills to join our team. If you are a detail-oriented and results-driven professional with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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