Quality Assurance Technician

Quality Assurance Manager

Participate to ensure that the site’s Quality System is maintained compliant to regulatory and GxP compliance requirements (pharmaceutical, medical devices, foods and cosmetic products).

Participate in the management of the site’s Quality Systems Documentation and reviews.

Participate in the Quality System Management including management of Non-Conformances, CAPAS, Change Control, Training, Effectiveness Checks, Risk Analysis report, PQR.

Support the Quality Team in the Authorities Inspections, Clients Inspections and Autoinspections.

Revision documentation related to each batch of product and participate in the proposal to the Qualified Person the release of the product (GMP, Medical devices, Food and Hygiene rules).

Review the Technical documentation of the CMOs and GDPs previous to release the product to the market.

Participation in facilities and equipment qualifications and process validations.

Collaboration in Quality postproduction task (complaints, enquiries, preparation of technical information according to the necessities of our clients).

Perform other functions and participate in projects not reflected herein based on the needs of the Quality Assurance department.

Bachelor's degree in Pharmacy, Science, Engineering or other education with experience in a similar position in Pharmaceutical Company.

More than 2 years of experience in Quality in health company, the experience in GxP Pharma Company will positively be assessed.

Knowledge in SAP, Veeva, ESKO will be valued.

Customer Orientation, Results-oriented, Initiative and proactivity, Communication and teamwork, Planning and flexibility, Transversality and Global Vision.

Fluent English and Spanish written and spoken.

Travel required in %.