SPS BE Junior Qualified Person
Sharp
Hamont-Achel
5 dagen geleden

To strengthen our team in Hamont-Achel we are recruiting for a Junior Qualified Person :

Position :

  • 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.
  • Release register.
  • 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
  • Profile :

  • 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
  • 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
  • Accurate
  • Organized work processes / set priorities
  • Offer :

    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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