Delegated 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.

· 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