QA Compliance

Brisbane  ‐ Onsite
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Keywords

Description

The Quality Assurance department has determined that due to its current and projected workflow, it will need the immediate assistance of a contractor who is capable of performing the following activities as a QA Contractor:

Responsibilities:
  • Maintain the Approved Vendor List and conduct vendor qualification, re-assessment evaluations as applicable
  • Maintain vendor files in relation to Licenses, GMP Certificates, Quality Technical Agreements, TSE/BSE Certificates, as applicable
  • Manage daily activities associated with the authoring, revising or Quality Technical Agreements for contract manufacturer/ laboratory, contract service providers (CSP) and warehouse and distribution facilities
  • Manage daily activities associated with the Vendor Audit Program for contract manufacturer/ laboratory, contract service providers (CSP) and warehouse and distribution facilities
  • Identify, schedule and ensure execution and completion of vendor audits in accordance with the Approved Schedule
  • Manage daily activities associated with the Internal Audit Program
  • Identify, schedule and ensure execution and completion of internal audits in accordance with the Approved Schedule
  • Manage the CAPA program and enforce CAPA closure in a timely manner
  • Assist with product complaints, as needed
  • Author SOP's related to supporting functional areas, as needed


Experience:
  • 5 - 7 years of experience in Quality Assurance with a focus in Vendor Management for a Global environment;
  • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors


Skills/Training:
  • Communication Skills:
    • Ability to work with a diverse group of personalities and individuals
    • Good writing and verbal communication skills
    • Strong technical background in the pharmaceutical, biotech, supply chain (distribution) or healthcare industry
    • Knowledge of cGMP and ICH guidelines for a US, Canada and EU market
  • Computer Skills:
    • Knowledge of Software: MSWord, MSExcel, MSPowerpoint, MSOutlook, MSProject, Adobe Acrobat, desired
  • Other Skills:
    • Ability to work independently and multitasking
    • Ability to set schedules and meet deadlines


Education:

B.S. or M.S. in a scientific discipline is preferred, or equivalent experience

To find out more about Real please visit www.realstaffing.com
Start date
05/2014
Duration
8 months
From
Real Staffing
Published at
03.06.2014
Project ID:
715203
Contract type
Freelance
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