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QTA Analyst

Expired
  • Salary: Negotiable
  • Job type: Contract
  • Location: South East
  • Sector: Science
  • Date posted: 09/10/2017
  • Job reference: J375379A

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QTA Analyst

Waterford
12 month contract

  • Provide analytical chemistry services and support to Site.
  • Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
  • Maintain, update and issue chemical methods, specifications and SOP's in compliance to pharmacopoeial and regulatory requirements.
  • Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP's and updates.
  • Trend such results, record on COA's where required and complete OOS's investigations on a timely basis.
  • Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
  • Ensure all quality documentation and records are complete and current

Compliance Related Tasks

  • Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
  • Ensure relevant procedures are correctly defined and followed
  • Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
  • Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
  • Checking/auditing laboratory notebooks and analytical reports
  • Ensure compliance to cGMP at all times

Qualifications:

  • Degree in Science (Chemistry or Biochemistry preferred).
  • Post-graduate studies as appropriate to augment primary degree.

Experience:

  • Graduate
  • 2-3 years' experience working in a manufacturing environment preferred - ideally part of which would be in the pharmaceutical sector.

Skills & Knowledge:

  • Operational experience of quality laboratories in a fast moving manufacturing environment.
  • Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability.
  • Understand relevant quality/compliance regulations.
  • Can manage projects to plan/budget.
  • Understands KPI's for the site

Additional Job Description:

  • Provide analytical chemistry services and support to Site.
  • Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
  • Maintain, update and issue chemical methods, specifications and SOP's in compliance to pharmacopoeial and regulatory requirements.
  • Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP's and updates.
  • Trend such results, record on COA's where required and complete OOS's investigations on a timely basis.
  • Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
  • Ensure all quality documentation and records are complete.

Please contact Kathryn on 016455250 or email for additional information