Quality System Specialist

International Permanent
  • Competitive Salary
  • Flexible Working

About Our Client

A privately owned global pharmaceutical company with operations through over twenty fully-owned affiliated companies around the world. The Company is a world leader in novel therapies for gynaecology and andrology.

Job Description

Digital Quality Management System

  • Implementation, maintenance and administration of new eQMS at corporate level.
  • Work with IT department to support validation activities of the eQMS.
  • Introduction of quality related modules in eQMS (documentation, training, change controls, CAPAs).
  • Integration of eQMS platform via building eQMS community in the organisation, as Quality Subject Matter Expert to deliver related trainings.

Documentation System

  • Identify and drive improvements/updates to the GXP documentation.
  • Lead implementation of Global documentation for manufacturing activities.
  • Work on harmonisation of processes and participate in improvement initiatives.

Audits Management

  • Act as a real partner in corporate audit programs (internal and external)
  • Manage auditors' qualifications, auditors community
  • Identify improvement of cross functional audit, related CAPAs, applicable KPIs

The Successful Applicant


  • Pharmacist or Engineer with Master's degree or Bachelors in Quality, Regulatory.
  • 3 to 5 years of experience in pharmaceutical or biotechnology industries.
  • Experience working with electronic Quality Management System a mandatory.
  • Relevant experience in either quality (regulatory, manufacturing, or development).
  • Understanding of GxPs, quality systems and regulations (EU, FDA and knowledge of Japanese or other geographies' regulations is a plus).
  • Knowledge and interest in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
  • Good communication skills

What's on Offer

- Competitive Salary

- Flexible Working

- Opportunity for progression and professional development

Meg Spillane
Quote job ref
Phone number
+44 207 269 2278

Job summary

Life Sciences
Healthcare / Pharmaceutical
Contract type
Consultant name
Meg Spillane
Consultant phone
+44 207 269 2278
Job reference