QA Technician β Plant, LICONSA
Responsibilities
- Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization.
- Actively participate in CAPAs, CCs and complaints management, preparation of PQRs, supplier homologation and update in accordance with internal procedures, GMP rules, authorities and customer requirements.
- Ensure EU & US GMP compliance.
- Homologate raw material suppliers and maintain the system; perform risk assessment.
- Prepare and support the annual audit plan and audit performance.
- Act as the company contact for quality queries with raw material suppliers or external services.
- Register, investigate and respond to quality complaints from customers; identify recurrence and tendency.
- Prepare PQRs according to timelines included in the annual plan, internal procedures and applicable regulations.
- Register...