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.
· 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
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.
Bram Weckx
+32 499 70 17 25
bram.weckx@sharpserviceseu.com