Quality Assurance (Cataluña)

We are seeking an experienced Quality Assurance & Compliance Project Manager in Barcelona or Madrid (Spain) to support our pharmaceutical clients in ensuring compliance with general regulatory requirements and driving continuous improvement of Quality Management Systems (QMS).

Responsibilities

• Manage, maintain, and improve Quality Management Systems (QMS) in compliance with GMP regulations and applicable regulatory requirements (EU GMP, FDA, ICH).
• Support clients in QMS implementation, remediation, and continuous improvement initiatives.
• Coordination and implementation of Contamination Control Strategies (CCS) of Annex1.
• Participate in internal audits, supplier audits, mock inspections, and regulatory inspections.
• Manage and support quality processes including Deviations, CAPAs, Change Controls, Complaints, OOS/OOT investigations, Product Quality Reviews (PQR/APR), Batch Record Review, Documentation Management.
• Coo...