Our client (a leading Biopharma) based in London is recruiting for an Interim Quality Assurance Manager, for a period of 3 months to work closely with the QA department and with internal and external customers to achieve a common goal, using ‘one plan’ to ensure GxP activities e.g. GDP, GMP, GPvP conducted by SPE and Global QA are implemented and controlled.

Role Purpose:

  • Support the maintenance of the Quality Systems to ensure GMP/GDP/GVP compliance
  • Support the investigation of deviations and complaints, maintaining the paper based deviation system; log issues and CAPA, track status, assess for effectiveness and generate metrics
  • Support the maintenance of the paper based Change Control System; log changes, track status, assess for effectiveness and generate metrics. Ensure CC are progressed to closure
  • Proactively review and critique QMS documentation and provide feedback to support continuous improvement initiatives
  • Generate procedures and controlled forms/ processes to support GxP activities.
  • Support the review of the SOP system
  • Support Internal Audit Programme against an agreed schedule either as a Lead Auditor or Support Auditor
  • Provide support/ lead QA projects as required to support SPE objectives especially serialisation
  • Support SPE with the interpretation of Product Dossier(s) and regulatory submissions, as required
  • Support the effective on boarding of new SPE employees by providing GxP and training
  • Support the ongoing training of SPE employees by providing Quality-related training on an ad hoc basis

Requirements include:

  • Life Sciences/Pharmaceutical background.
  • Knowledge of how procedures do or don’t comply with relevant standards, guidelines and regulations including, but not limited to, European Directive 2003/94/EC for Good Manufacturing Practice, European Union Guidance on Good Manufacturing Practice Part 1: Basic Requirements for Medicinal Products, Guidelines on Good Distribution Practice of Medicinal Products for Human) 2013/C 343/01

Location - Central London

Duration and days per week - 3 months (5 days per week)

Keywords: Interim, London, Contract, Quality Management, Quality Assurance, QA, Quality, Systems, Quality Manufacturing Systems, QMS, GMP.

To register your interest in this opportunity please forward an up-to-date CV to resourcing@pir-resourcing.com or contact Jo or Jasmin on 01480 499580, quoting reference 882450 and advising current availability and anticipated day rate.