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Qualified Person (Pharma)
My client is a multi-national pharmaceutical manufacturing company, with head quarters in Co Armagh. We are recruiting a Qualified Person to join their Pharma Services team in Co Louth.
To act as a Qualified Person (QP) and perform their duties as directed in Annex 16 of the EU Guide to GMP, the applicable Code of Conduct and EU legislation.
- Ensure that each batch of commercial product manufactured and/or packaged has been checked for compliance with the Marketing Authorisation or Product Licence, EU GMPs and the requirements of the Quality Technical Agreements in place with Contract Giver, prior to QP certification of each batch.
- Ensure that each batch of investigational medicinal product manufactured and/or packaged has been checked for compliance with the Product Specification File and/or IMPD, EU GMPs and the requirements of the Quality Technical Agreements in place with Contract Giver, prior to the QP certification of each batch.
- Review and approve Annual Product Reviews/Product Quality Reviews.
- Attend teleconferences/meetings, initiating QP related discussions for new or ongoing business and offering advice on questions, as appropriate.
- Provide QP support to internal project teams.
- Represent the Quality Department during customer audits, regulatory inspections and client visits.
- Review and approve Quality Technical Agreements with Contract Givers and Pharma Services Contract Acceptors, who provide support services to facilitate the QP certification of products.
- Provide input into the development and maintenance of the Pharmaceutical Quality System.
- Ensure appropriate QP oversight of the Pharmaceutical Quality System by reviewing Key Performance Indicators related to its operation.
- Review and approve key quality system documentation, such as change requests, deviation reports, suspect analytical result investigations and product complaint investigations.
- Review and approve (as applicable) Pharma Services’ policies, guidelines, procedures and specifications.
- Provide QA/QP input into risk management programmes and quality system initiatives running within Pharma Services.
- Follow up on queries which may impact on product quality with internal and/or external contacts as required.
- Participate in the internal and external audit schedules.
- Stay current with legislation, guidelines and other expectations of the pharmaceutical industry especially in relation to GMP, Quality Management and QP responsibilities.
- Eligible to act as a Qualified Person under Permanent Provisions of Directive 2001/83/EC
- Previous significant experience working within an established Pharmaceutical Quality System.
- Previous experience of QP certification of medicinal products.
- Proven knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products in Europe
- Good pharmaceutical product and process understanding.
- Good working knowledge of Pharmaceutical Quality Management Systems
To discuss this, or any other role within Life Science, please contact Seamus on (phone number removed)
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