QA Compliance Technician

We are a Spanish pharmaceutical company engaged in the research and development, manufacturing and marketing of small molecules and biological medical products.

We likewise use our sales channels to market a number of licensed pharmaceutical products, imaging contrast agents and other products for hospital use, as well as OTC pharmaceuticals.

All of this is carried out through our specialized sales team formed by more than 260 people who promote the products with specialized medical professionals and in hospitals and pharmacies.

1. Perform departmental activities to comply with GMPs and the company's Quality system.

2. Ensure compliance with the company's Quality System, together with the person in charge.

3. Management and coordination of CAPAs arising from quality systems.

4. Manage and perform internal audits as appropriate, according to specific procedures.

5. Manage and participate in the supplier qualification process.

6. Follow-up on actions derived from internal and external audits.

7. Management of the Site Master File.

8. Management of annual product reviews. PQR.

9. Implement and close the CAPAs for which you are responsible within the estimated timeframe.

10. Collaborate in the implementation of the continuous improvement program and establish quality metrics for systems/processes.

11. Knowledge of medical device legislation and applicable standards.

12. Management and/or support of Change Control.

13. Coordinate and review quality agreements with customers and suppliers.

14. Regulatory support to the registration area regarding quality compliance topics

Collaborate in the company's data integrity program

Permanent

The required education for the job is:

Bachelor's Degree (mandatory).

3 to 5 years