Ref: 882450 Interim Quality Assurance (QA) Manager

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Company Name .
Location London UK, United Kingdom
Category Quality
Job Type Interim
Sector Pharmaceutical
Level Manager

Description

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.