Specialist, Quality Assurance

Overview

Job Title : Specialist Quality Assurance

Location : Madrid, Spain

The Quality Department has the responsibility for managing key elements of the local GDP / GMP Quality Management System (QMS) and monitoring its effectiveness. The department must ensure that regulatory (EU + Local) and internal requirements are always met for products marketed by Organon. The department is also the primary contact during regulatory inspections. The aim of the role is to provide direct support to the Department Lead by conducting the day-to-day quality activities of the Quality Department in Spain and Portugal required by Good Distribution Practices (GDP) as well as by Corporate Policies. The scope includes activities related to GDP as well as MAH responsibilities.

Responsibilities

• Management of local procedures and training
• Deviation management and monitoring, CAPA, change control and risk assessment
• Preparation and / or review documentation for new batches and return management
• Management of complaints, incidents and quality queries related to product stability
• Participating in market recalls and mock recalls
• Monitor and document product destruction
• Self-Inspection planning, execution and documentation
• Support customer qualification requests and periodic verification
• Handling of temperature excursions and other logistics events during transport, warehousing and distribution
• Quality oversight of the local 3PL; support Organon partners regarding 3PL operations compliance
• Support notification of product shortages to Health Authorities and related communications
• Preparation of local and cluster Quality team meetings
• Support in preparation, performance and follow-up activities related to internal and / or external audits as well as inspections by Health Authorities
• Preparation of KPI
• Support in developing local QMS and implementing new regulations and Organon global quality system
• Participate in Quality-based projects as part of multidisciplinary teams as required

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What we offer

As an equal opportunity employer, we welcome applications from candidates with a diverse background and are committed to creating an inclusive environment for all our applicants.

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