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Qualified Person (QP)

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Cork
  • Sector: Scientific
  • Date posted: 27/09/2017
  • Job reference: J374712A

Qualified Person (QP) for Integrated Process Team

Description

The IPT ( Integrated Process Team) Qualified Person will be accountable to ensure straight through product flow and to ensure the team meets all product quality and compliance requirements to enable disposition for each batch, through the implementation and oversight of the Quality Management Systems for the IPT. This requires the management of a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment. The IPT QP will be an active member within the cross functional IPT Team providing independent quality support, guidance and expertise on all Quality Assurance and cGMP compliance aspects.to ensure the success of the IPT. The IPT QP will model the company's leadership behaviours and understand the production principles to drive a culture of continuous improvement building a High Performance Organisation. Primary activities/responsibilities:

  • Carry out the responsibilities of the Qualified Person as per the requirements of EU Directive 91/356/EEC.
  • Comply with requirements as documented in EU Directive from 2001 and the Eudralex Volume 4, Annex 16.
  • Batch Record Review for both drug product and drug substance.
  • Review of QC Analytical and Microbiological data.
  • Release of bulk drug product and drug substance batches.
  • Release bulk drug product batches to destinations other than those in the EU.
  • Active participation at the Deviation Review Board, Product Quality Reviews, Site Quality Council and other relevant forums pertinent to product quality review.
  • Champion the highest Quality and Compliance standards for the IPT.
  • Champion Permanent Inspection Readiness for the IPT.
  • Participate and Comply with the company Quality Management System (QMS) requirements, including ownership as required.

Qualifications

  • Quality and Process background with at least 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 2 years' experience in a Quality function.
  • Degree or 3rd level qualification (Science, Quality).
  • QP educational qualification.
  • Desirable evidence of Continuous Professional Development
  • Experience in Sterile manufacturing ( aseptic processing ) desirable
  • Preference for Lean Six Sigma Green Belt
  • Proven track record of providing independent Quality expertise to Manufacturing and or Laboratory functions.
  • Demonstrated ability to fully realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team.
  • Stakeholder management of multiple decision makers, corporate colleagues, auditors, cross functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
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