Qualified Person

2 weeks ago


Dublin, Dublin City, Ireland Sigmar Recruitment Full time

Executive Consultant: Quality & Regulatory - Pharma, Med Device & Biotech

I'm hiring a QP to join one of our top pharmaceutical clients, based in Dublin. This is a permanent role, with a strong salary package (depending on experience). You MUST have experience on a QP license in your previous role/roles.

Position Summary

The QP will be eligible to be listed on the license. Reporting to the Head of Quality, the QP will be responsible for QP Confirmation of the partial manufacturing of a medicinal product ('QP Confirmation'). Prior to batch release to the sponsor, the QP must personally ensure that:

  • The type of manufacturing is permitted under the terms of the manufacturing / importation authorisation.
  • Any additional duties and requirements of national legislation are complied with.

The QP is also responsible for developing and demonstrating Quality culture and Quality leadership at the company and in supporting the Head of Quality to ensure that Quality and Compliance requirements are followed in line with business needs.

Key Responsibilities
  • Support the Head of Quality in managing the Batch Certification processes and procedures. Where any delegation occurs, the QP will ensure that relevant processes and procedures are in place to support delegation and assure themselves that reliance on delegation is well-founded.
  • Own and manage QP to QP arrangements and contracts e.g. drug substance batch certification from company to a client DP site.
  • Support the Head of Quality in ensuring that the quality system meets the requirements of EU GMP and, in particular Annex 13 and Annex 16 of these GMPs.
  • Review and approval of all major and significant Quality events such as deviations, complaints, including involvement in triage where appropriate.
  • Assessment of impact of any change to product manufacturing or testing per change control procedure.
  • Maintain a level of training and qualification commensurate with undertaking required duties and licensed activities.
  • This includes the Quality Oversight on the floor role for QA during GMP operations.
  • QP approval of technical agreements for GMP services related to licensed activities.
  • Active role in Quality risk assessments in particular as pertain to starting materials.
  • Partake in Quality Management Review.
  • Identify and implement continuous improvement activities in the PQS.
  • The QP will be the named primary contact for regulatory authorities in the event of quality defect or recall.
Experience & Qualifications
  • Primary degree in a relevant Life Sciences discipline (such as Chemistry, Biochemistry, Microbiology, Pharmacy).
  • QP eligible by way of relevant postgraduate qualification / degree in Pharmacy.
  • 5-10 years' experience in a Quality role in a GMP-regulated pharmaceutical / biopharmaceutical company including drug substance manufacturing.
  • 1-3 years' experience named as a QP on a licence.
  • Experience of Quality Risk Management principles per ICH Q9 r1 and sound risk-based decision making is essential to this role.
Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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