QA Technician
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Overview
Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Actively participate in the CAPAs, CCs and complaints management, preparation of PQRs, supplier homologation and update in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance.
Responsibilities
Raw material suppliers homologation and system maintenance, risk assessment performance. Audits annual plan preparation and support regarding the audit performance. The role is a contact person of the company regarding quality queries to be managed with raw material suppliers or external services.
Quality complaints from customers: register, investigation and response. Recurrence and tendency identification.
PQR preparation according to timelines included in the annual plan, internal procedures and TA in force.
CAPA and CC system: register, evaluation and follow up. Performance of the specific task assigned to.
Training: GMP basic training to new staff. Register and follow up.
SOPs: to prepare or update specific SOP related to the activities in charge of.
Collaborate in external audits from customers and Authorities and conduct shelf-inspections according to the annual plan.
Support to Customers and Authorities request for quality and technical issues.
Competencies / Career Level
Education:
Degree in Pharmacy or Chemistry or Sciences.
Languages:
Intermediate or high level of English required and bilingual in Spanish.
Experience:
A minimum of 3 years’ experience in a similar position.
Specific Knowledge:
Knowledge of EU & US GMPs, quality systems (CAPAs, PQRs, audits support, supplier management, change controls, etc.) in pharmaceutical companies. SAP and Trackwise knowledge is valuable. xpzdshu
EEO Statement
El grupo InsudPharma es consciente que la gestión empresarial tiene que estar en consonancia con las necesidades y demandas de la sociedad, y por ello asume el compromiso de igualdad de oportunidades y trato entre hombres y mujeres, tal y como se recoge en la normativa vigente en la materia -Ley Orgánica 3/2007, y no discriminamos a ninguna persona por motivos de etnia, religión, edad, sexo, nacionalidad, estado civil, orientación afectiva o sexual, identidad o expresión de género, discapacidad, o cualquier otra circunstancia personal o social.
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