Qualified Person (QP) Longford | Collins McNicholas

Qualified Person (QP) Longford

  • Reference: SJ44885
  • Job Type: Permanent
  • Location: Longford, Roscommon, Westmeath
  • Category: Science, Pharmaceutical & Food

Qualified Person (QP) Longford

 

We currently have an opportunity for a QP (Qualified Person) to join a small pharmaceutical manufacturer in the midlands. This role may suit an entry level QP looking to gain experience on the licence or even a more experienced QP – our client will be open to either option.

 

Main responsibilities with the role:  

  • Ensuring that duties carried out in accordance with Article 22 of Directive 75/319/EEC and Annex 16 of Volume 4 of the Eudralex.

  • Release for sale of each batch of finished product in accordance with SOP, ensuring that the requirements of cGMP, the Manufacturing Authorisation & the Manufacturing Licence are met.

  • Ensuring that all manufacturing checks and tests have been performed in accordance with approved procedures and account taken of production conditions and manufacturing records and that all Production and QC documentation has been completed and endorsed by appropriate qualified personnel.

  • Ensuring that any additional sampling, inspection or analysis have been carried out or initiated as appropriate to cover planned changes or deviations.

  • Assignment of batch disposition and allocation of batches for dispatch.

  • Liaison with contract manufacturers in relation to Quality Agreements and requirements for QP Batch Release for Sale.

  • Assessment of Deviations, Discrepancies, Incidents, Out of Trend & Out of Specification investigations as well as CAPA evaluation and review. Identification of critical issues particularly in relation to incidents that may impact Patient Safety & Efficacy.

  • Periodic Quality Review compilation & approval.

  • Assessment & disposition of returned goods.

  • Active participation in daily SDI meetings (working directly with Production, Engineering, QA and QC)

  • Working as part of the internal supply chain to ensure that finished product is safe, effective and of required quality in order to meet the supply demand of patients/end users

  • Monitoring the quality risks for Finished Product and provide effective management of any incidents that could result in a Quality Defect Notification

  

Education and Experience: 

  • Third level Scientific Degree

  • Education to meet the requirements for position of Qualified Person as defined in Article 49 Directive 2001/82/EC.

  • 5 years industrial/pharmaceutical experience

  • Experience in aseptic production

  • Intellectual capacity to appreciate European and Overseas regulations

  • Good working knowledge of current GMP requirements (EU & Rest of World).

  • First-hand experience in dealing with the HPRA/FDA during regulatory inspections

  

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!


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Davin Ferguson

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  • Davin Ferguson
  • Senior Recruitment Consultant
  • 071 9140251
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