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Qualified Person

Date: 22-Sep-2022

Location: Oxford, GB

Company: oxfordbiom

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

 

Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines.  The team are accountable for internal and external audits, quality compliance and control.

 

We are currently recruiting for a Qualified Person to join the team.  The purpose of this role is performing batch certification and helping to direct organisational and operational Quality activities.

 

Your responsibilities in this role would be:

 

  • Responsible for certifying that Investigative Medicinal Products (IMPs) and or commercial API are manufactured in accordance with GMP
  • Member of Quality Leadership / Steering Team
  • Input on quality policy, objectives and deliverables for business.
  • Input on quality decisions and go-forward strategy, balancing quality with business objectives
  • Participation at project meetings, client / partner meetings
  • Be a key point of contact for external parties for quality.
  • Serving as EU Qualified Person (QP) for batch certifications in accordance with 2001/83/EC, 2001/20/EC and SI2012-1916
  • Overseeing BMR and supporting record review and approval (deviations, EM, analytical, OOS/OOT etc)
  • Providing guidance and integration of European and USA regulations
  • Ensuring GMP knowledge of self and others within both the Quality team and other function are kept up to date.
  • Participate as required in self-inspection activities and external audits
  • Host and support regulatory inspections, audits by clients / partners.
  • Maintain QMS oversight as part of QP operational responsibilities (EU GMP Annex16)

 

To be successful in this role, you will have the following skills and experience:

 

  • Life Science degree and / or post graduate
  • Must meet eligibility requirements combined with relevant biologics and steriles knowledge to be named on Manufacturer’s Authorisation for IMPs (or commercial API) from MHRA
  • Detailed knowledge of Guide to Good Manufacturing Practice
  • Expert knowledge of Validation and Quality Management systems
  • Working knowledge of Clinical Trials and IMP Regulatory system
  • Meets requirements of continuing professional development required to maintain QP status
  • Meets requirements of the Qualified Person as detailed in articles 49 and 50 of Directive 2001/83/EU and Medicines for Human Use (Clinical Trials) Regulation 2004
  • Extensive knowledge, interpretation and application of quality management within a GxP  environment for early phase clinical trials 
  • Experienced Pharmaceutical Auditor
  • Experience hosting regulatory inspections
  • Experience of managing/leading others

 

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 

Collaborate. Contribute. Change lives