The QA Manager is responsible for ensuring the development and implementation of procedural quality assurance measures for manufacturing activities and customer supply, in line with the quality and regulatory policies and objectives established by Company Management.
The role is responsible for the implementation, management and oversight of the processes forming part of the Quality Management System (QMS), including the related KPIs, and for ensuring that the QMS is correctly applied.
The QA Manager will manage QA activities at the manufacturing site, collaborate with the CMC function in preparing Module 3 of product registration dossiers, and act as Quality Representative.
The role also includes responsibility for performing the duties of Qualified Person (QP) in compliance with applicable legislation, including Italian Legislative Decree 219/2006, as amended, and the relevant EU Guidelines for Good Manufacturing Practice, including Annex 13 and Annex 16.
Experience: Minimum 10 years' relevant experience within the pharmaceutical or biopharmaceutical industry,
including significant experience in Quality Assurance within a GMP-regulated manufacturing or CDMO environment and substantial experience performing Qualified Person (QP) responsibilities.
Previous experience managing QA activities and personnel is required.
RESPONSIBILITIES
- Coordinate and manage QA activities, including Quality Control, validation, management of Corrective and Preventive Actions (CAPA), non-conformities, Risk Management Activities (RMA), change control, qualification and auditing of critical suppliers, product quality complaints, Product Quality Reviews (PQRs), and Batch Record Reviews for both portfolio products and products manufactured by third parties.
- Design, implement, monitor and continuously improve the QMS in accordance with applicable regulations.
- Assess the quality status achieved and report findings to Company Management.
- Support Legal Counsel in drafting contracts
📌 Quality Manager/QP (Vimercate)
🏢 Barrington James
📍 Vimercate
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