QA Compliance Leader- Lead Auditor

England
£35 - £50 per hour
18 Mar 2013
15 Apr 2013
RE-12455928
Rachel Smith
Healthcare
Contract
Full Time
Main Purpose

Ensure the organisations audit programme (internal and external) is controlled and managed as per regulatory requirements and to internal organisations standards.

Key Accountabilities
  • Ensures systems are in place to issue, control, periodically review obsolete and archive all quality relevant site documentation
  • Is the subject matter expert on site electronic quality systems - Mango, Trackwise and eDMS as appropriate
  • Ensures the site complaint and deviation investigation system work effectively to pre-defined timelines
  • Supports and supervises risk analysis and assessments and acts as moderator as necessary
  • In conjunction with the Quality Assurance Manager set the quality systems standards strategy to ensure licensed products and food supplements are manufactured in compliance with regulatory requirements
  • Work with the QC Manager to ensure QC systems are integrated in to the site quality systems
  • Generates the site Validation Policy and acts as a quality approve of validation documentation including computer validation and ensures electronic systems are validated according to organisation and GAMP requirements
  • Support business in GxP and internal audits
  • Develops and reports KPIs to measure improving performance of the quality assurance system
  • Develops actions together with the business for improving KPIs and general standards
  • Supports, classifies and supervises change control
  • Supports, assesses and closes deviations
  • Provides and facilitates training on quality
  • Supports NPD and extensions to current product portfolios where appropriate

Qualifications/Knowledge & Skills

(Essential)

  • Science Degree or relevant experience
  • Previous experience in a Quality Assurance Management role
  • Leadership skills with ability to influence
  • Validation experience in the Pharma industry
  • Confident user of IT systems
  • GAMP implementation experience
  • Excellent communication skills
  • Knowledge of quality management systems
(Desirable)
  • Previous experience of working in a Liquids manufacturing facility
  • Broad understanding of manufacturing operations business
  • Understanding of QC testing operations
  • QA systems audit experience
  • Well developed risk assessment skills
  • An understanding of the legal requirements, rules and guidance covering the manufacture of Pharmaceutical products in Europe
  • Assertive decision maker

If you are interested in this position and have the relevant experience please contact me asap on 0207 758 7322.

To find out more about Real please visit www.realstaffing.com