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

Your profile Degree in Health Sciences. Training in the Pharmaceutical Industry (Quality / Regulatory Affairs) will be valued

Member of the Spanish Pharmaceutical Society (desirable)

1-2 years’ experience in Quality (GMP / GDP) within the Pharma industry

Knowledge of EU quality-related regulations for medicines and medical devices

High knowledge of English (oral and written); Portuguese desirable

Knowledge of computer applications (e.g. Microsoft Office)

Organizational, analytical and conceptual thinking skills; structured and methodical with good dialogue and interpersonal skills, high motivation and learning capacity

Proactivity, communication and teamwork, customer orientation, initiative and flexibility

Ethics and Integrity, results-driven, fostering collaboration

Workplace : Madrid

What we offer Competitive salary

Attractive collective health care and insurance packages

Solid Pension Plan company paid

Annual bonus based on company performance

Flexible benefits

Numerous training, coaching, and e-learning modules for long-term development

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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