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Description Overview

The Release and Qualified Person (QP) Lead will be accountable for providing strong Quality Assurance oversight of commercial finished pharmaceutical products. This role is responsible for quality oversight and batch certification of finished products within the scope of the company’s Manufacturing and Importation Authorisation (MIA), as well as for fulfilling all statutory duties of the Qualified Person in accordance with applicable EU regulations.

The role will ensure stakeholder management and communication on prioritise throughout the business.

Scope of the Role

• 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 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 customer visits.
• Review and approve Quality Technical Agreements with Contract Givers and Perrigo 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) Perrigo policies, guidelines, procedures and specifications.
• Provide QA/QP input into risk management programmes and quality system initiatives running within Perrigo.
• Ensure stakeholder engagement.
• 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.
• Host Regulatory Authority audits and ensure preparation of such audits is actioned.
• Stay current with legislation, guidelines and other expectations of the pharmaceutical industry especially in relation to GMP, Quality Management and QP responsibilities including ensuring reports are also engaging in their development and knowledge of changes in regulations.

Experience Required

• Bachelor’s degree in Pharmacy, Chemistry, or Life Sciences.
• A minimum of 10+ years experience in quality assurance/control within the pharmaceutical industry.
• QP Status: Must meet educational and experience requirements specified in Directive 2001/83/EC
• Prior experience as a named Qualified Person (QP) at a licensed facility for several years
• Previous people management experience
• Strong working knowledge of cGMP in manufacturing and testing environments
• Clear, accurate technical and compliance-focused writing skills
• Experience supporting regulatory inspections and internal GMP audits preferred
• Proven ability to manage stakeholders and escalate issues appropriately