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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

QP Manager


Reference:SCAXBG-200065 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person, Quality Manager

QP Manager
Our client, a global healthcare organisation, are currently recruiting a QP Manager to join their team on a permanent basis.

Responsibilities

  • Lead and manage the QP team to meet site KPIs and objectives
  • Provide leadership to the team that leads to the achievement of company and site objectives, in terms of quality, compliance, service, cost and safety
  • The Qualified Person (QP) Manager is responsible for the disposition and release of product manufactured and/or packaged (inclusive of Investigational Medicinal Products (IMPs)) manufactured on site or from 3rd party manufacturers/ suppliers
  • Ensure each batch released has been produced and tested in accordance with the current EU/FDA GMP Directives and the relevant marketing authorization
  • Perform duties in accordance with the principles of Good Manufacturing Practices GMP and/or Good Distribution Practices GDP regulations and with the company requirements
  • Support the change control process, ensuring all proposed changes are appropriately documented and in compliance with cGMP and company policy, including validation documentation
  • Support the deviation management system, ensuring all investigations are thoroughly documented and in compliance with cGMP and company policy
  • Support health authority, customer and corporate inspections, including internal audit self-inspection programme
  • Manage the QP team to meet site, regional and global strategic goals and key performance indicators
  • Provide a service to internal departments at the site and suppliers/marketing affiliates for quality related queries
Requirements
  • A Bachelor's degree in a Science related discipline
  • Knowledge of EU quality-related pharmaceutical regulations
  • Qualified Person qualification is mandatory
  • Experience in Oral Solid Dosage pharmaceutical manufacturing would be beneficial
  • Strong organizational skills with the ability to multitask and prioritise workload
  • Excellent oral and written communication skills
  • The ability to be self-driven and capable of working on own initiative
  • Experience in performance management and personnel development
  • Minimum of 5 years working in a similar role or at a supervisory level within quality assurance