QP - growing company on Dutch border

One of my clients that are growing on the market is looking for a Qualified Person to join their small but strong team. You will feel very well supported as there is a family atmosphere where everyone helps each other out. This is a great opportunity to learn and get training to fully develop your skills and grow your value on the market!

Responsibilities

To strengthen their team in their location on the border of Belgium and the Netherlands, we are looking for a Qualified Person that will; Ensure that each batch has been manufactured and checked in compliance with the laws in and in accordance with the requirements of the marketing authorisation 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 quality system to assure the right cGMP level for the process and systems; Participate in cGMP improvement activities; Be the responsible pharmacist as in the: Royal Decree of 6 June 1960 Directive 2003/94/EC; 91/412/EC Directive 2001/83/EC; 2001/82/EC; Make sure each batch of medicinal product is packed and checked in compliance with pharmaceutical regulations and in accordance with the requirements of the marketing authorisation; Take care of 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

What we are looking for:

• 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
• Knowledge on Filling Weight regulations Ownership
• Team player, able to work with all levels in the organization
• Positive mind set / solution oriented

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via S.Thijs@nonstopconsulting.com. You can contact me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!