Job Description

Overview

Many medicines, even essential medicines, are not licensed for paediatric use. The use of unlicensed and off-label medicines for children has been common practice for years, meaning that children often may not receive the same quality, safety and efficacy from their medicines as adults. Many drugs used in children have not been adequately developed in paediatric indications resulting in “off label” use of unlicensed adult medicines in children.

Proveca was established in 2010 to address this issue. We specialise in identifying, researching and licensing off-patent medicines with unmet priority health care needs, with a focus on the paediatric market.

Vision

To be the leading Children’s Medicines Company in the world

Mission

Starting with the child in mind, we design, develop, and deliver medicines to address their unmet medical needs.

Values

We are a family of passionate pioneers

Location

Home-based, with travel to Manchester at least twice weekly and to Dublin occasionally, in line with the Company’s SMART Working Policy.

Role Purpose

To embed, manage day to day, and improve all aspects of quality management within Proveca.

Principal Responsibilities

• Oversight and maintenance of the Proveca Quality Management system in line with the GxP requirements
• Undertaking activities relating to management of the WDA for the UK
• Quality lead on computerized systems validation and compliance.

Role Responsibilities

• Develop and manage core quality management functions within the Proveca Quality Management System to ensure continued compliance and fit for purpose
• Introduction, review and updating of core documentation and ensuring required records are kept
• Manage a system for external and internal audits to ensure operational compliance with the QMS and drive continual improvement and efficiency.
• Support functions within the organisation with the application of quality risk management principles in key operations within the organisation.
• Ensure that products are managed and maintained in line with GxP requirements and the QMS processes, including:
  • Manage Product risk
  • Manage the stability programme for licensed products
  • Define transport validation requirements
  • Lead on Internal and external audit program
  • Ensure training programs in relation to the QMS are implemented and recorded.
  • Ensure that all direct and indirect staff are trained in compliance activities as appropriate.
  • Monitor and report on the overall quality / compliance activities, using metrics to measure success
• Support the review of global Quality / Compliance environment, highlighting opportunities / actions / associated mitigation / contingency strategies the business should consider / undertake
• Manage the assessment, approval and review of Suppliers and Customers, ensuring they hold valid authorisations and licences to undertake their activities.
• Undertaking oversight and release activities as part of operation as UK RP/RP(i)
• Support the management of wholesaling functions within the Proveca group, ensuring that the requirements of GDP are observed and maintained.
• Keep abreast of evolving regulations/legislation, and provide quality expertise to the R&D team in the development of new medicines and support with GxP knowledge.
• Support the implementation of new products into the Proveca QMS and ensure changes to the system are managed effectively.
• Lead on validation of computer systems in line with GxP requirements
• Knowledge of GCP/GVP useful but not essential