Senior Quality Assurance Specialist

Republic of Ireland  ‐ Onsite
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Description

Requirements:

The successful candidate will report to the Senior QA Manager and provide Quality oversight of Warehouse operations, including disposition of raw materials, project support and change control management.

Key Responsibilities:
  • Perform material/supplier investigations supporting raw material quality issues
  • Perform change control management of supplier initiated changes
  • May own specifications, non conformance & CAPA records and change records
  • Manage Raw Material reserve samples
  • Negotiate quality agreements with suppliers
  • Collaborate with Global SQM to provide supplier performance feedback (e.g. supplier scorecards, supplier audits, etc.).
  • May own site quality system(s) and standard operating procedures
  • May represent ACO on global network teams and support of new initiatives
  • Metrics compilation and reporting
  • Provide SAP expertise

Basic Qualifications/Experience:
  • University degree gained in Chemistry, Biology or Science related discipline.
  • Significant experience gained within the pharmaceutical or biotechnology industry.
  • Experience working with raw material suppliers
  • Batch Manufacturing
  • Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
  • Knowledge of applicable Regulatory requirements
  • Experience with Regulatory inspections desirable
  • Operational Excellence experience desirable
  • Experience leading cross-functional teams desirable
  • Experience utilizing Lean principles and a risk-based approach desirable
  • Experience working with teams and influencing decisions


This role provides very competitive hourly rates and they are looking for someone to start immediately. If you would like to apply please contact Sarah Irvine on or reply with your most recent CV.

We also offer shopping vouchers for any successful referrals.
Start date
10/2015
From
Real Staffing
Published at
07.10.2015
Project ID:
996804
Contract type
Freelance
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