Quality Assurance Specialist

  • Basis:  Full-Time
  • Closing Date:  11 Oct, 2019
  • Job Ref:  KMP-48254

Job Description

The Quality Assurance Specialist will be responsible for oversight of GMP practices and quality and compliance activities.

Duties:

  • Ensure harmonisation of QA practice at the Malta site concerning quality issues and keep the quality standard policy up to date according to Corporate, ICH, GMP and FDA guidelines
  • Work closely with the production and quality control to ensure their practice fully adheres to cGMP
  • Lead, author, and manage deviations (including OOS, OOT) and robust investigations and re-lated reports to closure within established timelines for the manufacturing department
  • Ensures adequate Root Cause Analysis tools are used for critical and major investigations
  • Provide timely updates to management on status of all GMP-related investigations
  • Work cross-functionally to assess and analyse deviations and investigations to determine im-pact
  • Monitor and ensure effectiveness checks of CAPAs are conducted
  • Manage GMP documents by writing, reviewing, and/or managing document workflows
  • Support data integrity reviews at the site

Minimum requirements

  • Relevant degree in a Scientific discipline
  • Comparable background and 2+ years of relevant QA experience in Pharmaceutical, Chemical, Biotech company.
  • Experience conducting quality investigations, root cause analysis and quality risk assessments
  • Knowledge of GMP standards
  • Strong organisation and presentation skills
  • Knowledge of FDA quality metrics
  • Excellent interpersonal and communication skills
  • Ability to work collaboratively with the Italian team
  • Must be a strong team player and effectively collaborate with internal departments
  • Knowledge of Italian will be considered as an asset