To strengthen our team in Hamont-Achel we are recruiting for a Junior Qualified Person :
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
Ensuring timely and adequate batch disposition decisions
Perform and / or assist with parts of various problem-solving duties which occur, including studying the situation, evaluation of possible solutions and options, deciding on most appropriate plan for solution, and approving plan of action
Provide training to other employees by demonstration, repetition, modelling, large group training, etc.
Coach staff in working with individuals on a regular basis to access, instruct and model
Assist in controlling the correct working of the quality management system
Decide on batch disposition of materials and final finished product 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 as back-up of the QP Lead
Review and approve final investigation reports on incidents, complaints and investigations as back-up of the QP Lead
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.
Responsible pharmacist of Enestia (Sharp Packaging Solutions)Belgium N.V. trading as Sharp Packaging Solutions as in the : Royal Decree of 6 June 1960Directive 2003 / 94 / EC;
91 / 412 / ECDirective 2001 / 83 / EC; 2001 / 82 / EC
Each batch of medicinal product is packed and checked in compliance with pharmaceutical regulations and in accordance with the requirements of the marketing authorization.
Batch documentation integrity, by means of batch record review, review of analytical records and other relevant batch information.
Oversee the quality system, evaluation and approval of Change requests, CAPA plans and outcome of quality reviews
Advice and approval of internal deviation handling and CAPAs
Master degree, industrial pharmacist.
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 HACCP and food regulations
Knowledge on Healthcare regulations.
Knowledge on Medical Device regulations
Knowlegde on Filling Weight regulations
Team player, able to work with all levels in the organization
High level of integrity
Think in processes
Positive mind set / Think in solutions
Organized work processes / set priorities
Sharp Packaging Solutions offers you a versatile and challenging job in a dynamic work environment. We create growth opportunities and, in addition to a competitive salary package, we offer you numerous additional benefits.
Type of contract : permanent employment
Time schedule : full-time
Regime : day shift (with sliding working hours)
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