I am recruiting a contract Qualified Person (QP) on behalf of our global pharmaceutical client.
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
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.
- 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
- 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, [email protected]