Collaborates to ensure that the site´s Quality System is maintained compliant to regulatory and GxP compliance requirements Collaborates in the management of the site´s Quality Systems Documentation and reviews.
Collaborates in the Quality System Management including management of Non-Conformances, CAPAS, Change Control, Training, Effectiveness Checks.
Support the Quality Team in the Authorities Inspections, Clients Inspections and Autoinspections
Acts as QP for the Certification of Conformance of the product (pharma, medical devices, food and hygiene products) according to the GMP (Annex 16) and the regulation in reference of these products of the products manufactured in the plant.
Reviews the Technical documentation of the CMOs and GDPs previous to release the product to the market.
Acts as technical provides oversight for the implementation of Regulatory Compliance (Module III) of the products and issues statements required.
Act as a QP deputy before the health authorities due to the absence of the QP
Required Education
Bachelor´s Degree in Pharmacy or training to act as Qualified Person (according to the Spanish Royal Degree 824/2010 art.17)
Required Skills and Experience
More than 5 years of experience in GxP pharma company manufacturing operations up of with more than 3 years in Quality Assurance Role