Qualified Person

Location
Dublin South, Dublin
Salary
Negotiable
Posted
16 Nov 2022
Closes
14 Dec 2022
Ref
BBBH5406
Contact
Sarah Savage
Sector
Scientific
Job Type
Permanent
Hours
Full-time

Qualified Person

I am recruiting a Qualified Person (QP) on behalf of our global pharmaceutical client based in Dublin.

Don't lose out on an opportunity to join a market leading biopharma company where innovation and support is embedded in culture, and where talent comes together.

Location: South Dublin, (Mon-Fri on site)
Salary: Excellent hourly rate on offer, contact Sarah Savage for more information


The role:

QP role provides a EU batch certification and release service to the Principal Trading Companies [PTC] and Trading Partners, to ensure compliance with the GMP aspects of the laws governing the importation of products into the EU. Work in intimate team, report to Quality Director.

Your Responsibilities:

  • Identify and support management of incidents as required, ensuring supply sites have all the information required to lead the investigation and incident resolution. EU/UK Importation team may be required to run LICs/PIRCs dependent on where the incident occurred.
  • Lead the EU/UK Importation operations on behalf of the PTC.
  • Ensure oversight of supply site operations via formal quality meetings with the site, involvement with internal audits undertaken at the sites and visits to view operations as required. Support regulatory inspections of supply sites, as required.
  • Perform audits of the importation supply chain to ensure compliance with GMP, GDP and MIA authorisation
  • Actively represent EU/UK Importation QP certification operations at Quality Councils and on assigned projects, as required.
  • Educate and train wider client organisation on the QP certification requirements ensuring compliance.
  • QP certify all batches of Pharma products imported to the EU, portfolio may be extended to cover multiple dose forms
  • Provide relevant information to the Consumer organisation to allow their nominated QPs to operate a compliant batch certification process in accordance with the MIA requirements.
  • Be a lead point of contact with non-EU/ UK based manufacturing Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
  • Provide oversight to the existing test arrangement to ensure EU/UK product testing requirements are met
  • Co-ordinate with the Quality Director in the following areas: QMS implementation, Quality System, Quality Councils, Licenses, Resource management


Requirements:

  • Science degree and >5 years' experience in pharmaceutical manufacturing and quality operations preferred.
  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC
  • Experience with the batch release of major dose forms [tablets, cream/ointments], aseptic sterile manufacture and biopharm products
  • Experienced in UK / EU inspections
  • Experienced in application of GPS thinking and tools and knowledge of performance measures
  • Demonstrated experience of working in QA batch release operations.


If you are interested in this QP role, please contact myself through LinkedIn or directly to arrange a confidential follow up call with myself: 00 353 (0) 86 025 7479, sar[email protected]

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