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

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

Member of the Spanish Pharmaceutical Society (desirable)

1-2 years’ experience in Quality (GMP / GDP) within 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, information management, structured and methodical person, good capacity for dialogue and personal relationships, high motivation and learning capacity

Proactivity, communication and teamwork skills, eager to learn and take on challenges, with internal and external customer orientation, initiative and flexibility

Has Ethics and Integrity, results driven, foster collaboration

Workplace in 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 job opportunities and development

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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