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 16 to the EU Guide to Good Manufacturing Practice Title: Certification by a Qualified Person and Batch Release and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC.

· Oversee the Quality system to fulfil the Batch Disposition task in line with Annex 16 to the EU Guide to Good Manufacturing Practice Title: Certification by a Qualified Person and Batch Release and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/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 Sharp quality system to assure the right cGMP level for the process and systems at Enestia (Sharp Packaging Solutions) 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 (Sharp)Belgium N.V. trading as Sharp as in the:

o Royal Decree of 6 June 1960

o Directive 2003/94/EC; 91/412/EC

o Directive 2001/83/EC; 2001/82/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 Sharp.

· Act as lead auditor during supplier audits.

Jouw profiel

· Master degree, industrial pharmacist.

· QP Accreditation, according

o Royal Decree of 6 June 1960

o Directive 2003/94/EC; 91/412/EC

o Directive 2001/83/EC; 2001/82/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 solutions

· 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 bestellingen opmaken
  Leveringen controleren
  Producten presenteren
• De geneesmiddelen verstrekken aan de persoon met zorgbehoefte of aan de zorgverlener
  Informeren over de voorgeschreven behandeling

Aanbod

At Sharp, 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
+32 499 70 17 25
bram.weckx@sharpserviceseu.com