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Qualified Person

Job LocationNorthumberland
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-timeB

Job Description

Leading Pharmaceutical Development and Manufacturing Company based in Northumberland seeks an experienced Site Qualified Person (QP).About the role:To act as the key contact point for all QA and GMP issues on the Site, for products imported into or manufactured on behalf of the Site.Duties may include:

  • To act as "Qualified Person" for release of products to the market according to the Human Regulations Act and the Directive 2001/83/EC and 2001/20/EC and as named on the Licences.
  • Act as QP for all products manufactured and packaged at the site
  • To ensure product is made in accordance with manufacturing licences and equivalent marketing authorizations
  • Assure product, process and facilities comply with national and global regulatory requirements in alignment to the site policies
  • Provide quality oversight of all activities on site and of subcontractors
  • To actively participate in/chair Site Quality Review Team Meetings
  • To ensure any significant quality or compliance issues are escalated to senior management
  • To review and approve quality documentation
  • To conduct internal audits and advise on corrective action
  • To conduct external audits of supplies vendors, contractors and service providers
  • Provide support for customer visits and audits
  • Provides pro-active support for and initiates quality improvements within Manufacturing and Quality
  • Deliver training
  • Provide QA support to manufacturing, packaging and supply chain, and to all business areas
  • Provide advice, guidance, support and mentoring to all staff with the Morpteth site in matters relating to the safety, quality and efficacy of the manufacturing and distribution of medicinal products and investigational medical products
  • Participate as a member of the site Quality Management Review Team
  • Review, assess and managemetn of quality risk
  • Drive Continuous improvement
  • Champion Quality Agenda
Skills and experience:
  • Eligible by MHRA to act as the Qualified Person (QP) for Certification and Batch Release of finished products and Investigational Medicinal Products
  • Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.
  • Proven technical ability including: knowledge of GMP/GLP, QMS, test method validation & equipment qualification, Lean and 6 sigma continuous improvement.

Keyskills :
GMPManufacturingPharmaceuticalProductionQualified Person

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