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