QA Technician

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.