Job Purpose
Key Responsibilities
-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 Analisys 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 qualificacions 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.Required Education
-Bachelor's degree in Pharmacy, Science, Engineering or other education with experience in a similar position in Pharmaceutical CompanyRequired Skills and Experience
-More than 2 years of experience in Quality in heath company, the experience in GxP Pharma Company will positively be assessed.Technical Competencies
-Knowledge in SAP, Veeva, ESKO will be valued will positively be assessed.Required Behaviours and Competencies
-Customer Orientation
-Results-oriented
-Initiative and proactivity
-Communication and teamwork
-Planning and flexibilityFlexibility
-Transversality and Integral VisionRequired Languages
-Fluent English and Spanish written and spokenTravel required in %