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Qualified Person (Clinical)
My client is a multi-national pharmaceutical manufacturing company, with headquarters in Co Armagh. We are recruiting a Qualified Person to join their Clinical Services team in Co Lough.
The role of the Qualified Person is integral to the success of the QP Services Department in delivering expert advice and ensuring QP Certification of clinical supplies (from Clinical Services Ireland), is performed in accordance with regulatory requirements and customer expectations. The QP must be present at the facility when undertaking their legal duties..
Professional & Consultancy Duties
- Act as a Clinical Services Qualified Person under EU Directive 2001/20/EC for the QP Certification of batches imported to, or processed at Clinical Services, fulfilling the requirements specified in Article 13.3 and undertaking the duties outlined in Annex 13 and Annex 16.
- Operate within the Code of Practice for Qualified Persons in the pharmaceutical industry as relevant to the manufacture of clinical trial materials and licensed materials, as appropriate.
- Act as a Clinical Services Qualified Person in the UK adhering to any additional UK legislation as applicable when undertaking duties at other facilities.
- Remain current with industry practices and technological advancements relating to IMPs for QP Certification. Keep up-to-date with country specific requirements and Clinical Trial legislation relating to Clinical Services business, offering expert advice in a consultancy role as the need presents itself.
- Remain familiar with the structure and content of a Clinical Trial Application, the most commonly occurring issues and be able to offer customers guidance on best practice.
Supply Chain Assessment
- Evaluate study supply chains and assess, as applicable, each site involved to ascertain compliance with the required standards of GMP.
- Audit manufacturing, testing, packaging/labelling and storage sites as required. Compile audit reports to a high standard in accordance with the requirements of Annex 16.
- Review and approve QP Declarations, as required.
Activities in Support of QP Certification
- Review QP Study documentation pertaining to pending releases and become familiar with the specifics of the Clinical Trial.
- Review study and lot specific documentation necessary to facilitate QP Certification. Use technical knowledge to assess the criticality of any issues. Confirm compliance with GMP, the Clinical Trial Authorisation and the Product Specification File.
- Assess stability data in light of pending expiry updates.
- Ascertain the status of the Clinical Trial Application in each participating country prior to QP Certification, considering the impact of Substantial Amendments, Non-Substantial Amendments or Notifications as applicable.
- Perform QP Certification in accordance with the schedule. Proactively highlight matters and interdependencies that could impact on QP Certification timelines, ensuring the customer and project staff are kept informed. Assess the impact of such and provide advice on avoidance strategies.
- Participate in Internal Audits as required.
- Maintain oversight of the global Clinical Services QMS and be involved in related activities. In doing so remain knowledgeable of changes, quality events, internal audits, regulatory inspections through the various communication forums, such as, attendance at management review meetings.
- Fulfil any necessary administrative duties required with QP activities.
Customer Service Duties
- Ensure all customer contact, oral and written, is carried out professionally in order to develop and maintain good working relationships with each customer (both internally and externally).
- Review and follow through on all customer queries received, ensuring a response is provided in a timely manner.
- Co-ordinate/attend internal/external teleconferences/meetings, initiating Qualified Person related discussions for new or ongoing business, as required.
- Represent the QP Services aspects of the business during customer audits and sales visits, promoting Clinical Services’ expertise in Qualified Person related activities, in the generation of new or on-going business.
- Eligible to act as a Qualified Person having been previously named on a Manufacturing Authorisation
- Honours Degree in Biology, Pharmacy, Chemistry or related subject (or equivalent)
- Experience in undertaking the routine duties of a Qualified Person
- Experience in auditing suppliers, API facilities, drug product manufacturing, packaging or testing sites
- Experience in more than one dosage form
To discuss this, or any other role within Life Science, please contact Seamus on (phone number removed)
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