Specialist, Quality Assurance

Join to apply for the Specialist, Quality Assurance role at Organon España.

The candidate must be based in Madrid (Spain).

Overview

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 both 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 of application includes activities related to good distribution practices 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 the customer qualification requests and the periodic verification
• Handling of temperature excursions and other logistic events during transport, warehousing and distribution
• Participating in quality oversight of the local 3PL. Support the business with Organon partners pertaining to the compliance of 3PL operations according to Organon guidelines.
• Support notification of product shortages to Health Authorities and related communications
• Preparation of local and Cluster Quality team meetings
• Support in the preparation, performance and follow-up activities related to internal and / or external audits as well as to inspections by the Health Authorities
• Preparation of KPI
• Support in the further development of local QMS and in the implementation of new regulations and Organon global quality system
• Participate in Quality based projects working as part of a multidisciplinary team as required

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What We Offer

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. We have a current local Equity Plan that ensures equal treatment and opportunities for all our employees and candidates.

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