Functie

Delegate Qualified Person

· Act as a delegate QP to ensure that each batch has been manufactured and checked in compliance with the laws in and in accordance with the requirements of the marketing authorization

· Act as a delegate QP by performing batch disposition and subsequent registration of the batch in the release register in line with Annex to the EU Guide to Good Manufacturing Practice Title Certification by a Qualified Person and Batch Release and Article of Directive //EC and Article of Directive //EC.

· Oversee the Quality system to fulfil the Batch Disposition task in line with Annex to the EU Guide to Good Manufacturing Practice Title Certification by a Qualified Person and Batch Release and Article of Directive //EC and Article of Directive //EC

· Evaluate and approve Changes proposed through the Change control system.

· Review and approve final investigation reports on incidents, complaints and investigations

· Participate in the enhancement of the Employer quality system to assure the right cGMP level for the process and systems at Enestia (Employer ) Hamont NV.

· Participate in cGMP improvement activities.

· Ensuring timely and adequate batch disposition decisions

· Participate in projects and contribute to project execution, validation activities and strategy, compliance to existing legislation or customer requirements and correct implementation of the project in the production environment.

· Provide training to other employees by demonstration, repetition, modelling, large group training, etc.

· Assist in controlling the correct working of the quality management system. Oversee the quality system, evaluation and approval of Change requests, CAPA plans and outcome of quality reviews

· Write APR / PQR on a timely basis.

· (Delegate)Responsible pharmacist of Enestia (Employer)Belgium N.V. trading as Employer as in the

o Royal Decree of June

o Directive //EC; //EC

o Directive //EC; //EC

· Batch documentation integrity, by means of batch record review, review of analytical records and other relevant batch information.

· Key (support) role in client and authority audits of Employer.

· Act as lead auditor during supplier audits.

Jouw profiel

· Master degree, industrial pharmacist.

· QP Accreditation, according

o Royal Decree of June

o Directive //EC; //EC

o Directive //EC; //EC

· Completed with relevant training and courses

· A first experience in a QP role for pharmaceutical manufacturing

· Active in depth knowledge on international cGMP guidelines and pharmaceutical regulations.

· Knowledge on Medical Device regulations

· Ownership

· Team player, able to work with all levels in the organization

· High level of integrity

· Think in processes

· Positive mind set / Think in

· Decision maker

· Accurate

· Organized work processes / set priorities

Acties realiseren Geneesmiddelenbewaking organiseren De ontvankelijkheid van het voorschrift controleren
Onverenigbaarheden, tegenindicaties, ... identificeren en indien nodig de voorschrijvende arts contacteren De administratieve taken en de geneesmiddelenverstrekking opvolgen in het orderboek, het register van verdovende middelen, ... Het personeel technisch ondersteunen bij de interpretatie van voorschriften en de posologie
De voorwaarden van de geneesmiddelenverstrekking controleren De status van de productvoorraad opvolgen en besingen opmaken
Leveringen controleren
Producten presenteren De geneesmiddelen verstrekken aan de persoon met zorgbehoefte of aan de zorgverlener
Informeren over de voorgeschreven behandeling Aanbod

At Employer, we strive to create a work environment where all employees can make the most of their skills. We offer you a versatile and challenging position in a dynamic working environment and we create numerous career opportunities. You can count on a suitable salary that is supplemented with numerous benefits, such as group and hospitalization insurance, meal vouchers, gift vouchers and other benefits.

Solliciteren

Bram Weckx
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