We have a new opening for a Qualified Person for our Pharmaceutical Manufacturing client based in Dundalk. You will be a key member of the Quality leadership team. As the senior Qualified Person (QP) you will fulfill QP duties in relation to batch release of commercial (product for sale or supply in the EU or for export) and clinical products. As the site Senior QP you will lead and mentor a team of other site QP's.
Qualified Person responsibilities:
• Batch release of Drug Substance manufactured and the release of Drug Product manufactured at other Biologics sites.
• Responsible for ensuring that, prior to the certification of any given batch is manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file/QAA and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch as detailed in Annex 16.
• Perform QP review of Deviations, CAPA’s and Change Controls.
• Lead and participate in investigation of product/facility deviations and investigations including root cause analysis. Escalate and/or cascade technical/quality issues to management.
• Provide clear, direct, and timely verbal and written communication to stakeholders.
• Participate and act as an SME in internal audits or host internal audit team & regulatory inspections (e.g. HPRA)
Qualified Person requirements:
• QP Qualification, meeting the requirements as set out in EU Directive 2001/83/EC for Medicinal products for human use.
• Degree level Qualification in Biopharmaceutical Science or other related science discipline.
• The QP should ideally have minimum 3 years’ experience named on an MIA and actively performing QP release. It is preferable the QP performed release of drug substance or drug product in a sterile or aseptic manufacturing facility.
• Ideally the candidate should have approximately 8 years’ QA experience in a cGMP regulated manufacturing environment with a thorough understanding of compliance.
• Candidates with clinical trial supply experience are preferred.
**FULL SPEC ON APPLICATION**
For a confidential discussion, please contact Tina Cornally.