Senior QC Reviewer-151860

Company
PPD
Location
Europe, Middle East & Africa-Ireland-Westmeath-Ath
Salary
On Application
Posted
21 Nov 2018
Closes
10 Feb 2019
Ref
151860
PPD provides laboratory services that are designed to increase speed and precision.
Our GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Our QC Data review team supports the analytical laboratories.

We are currently seeking a Senior QC Reviewer to join our growing team based permanently at the Athlone site.

Key responsibilities:

  • Ensures the quality of laboratory data and reports.
  • Reviews chromatographic data and related notebooks as specified by Standard Operating Procedures (SOPs).
  • Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
  • Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation.
  • Reviews complex sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
  • Validates large and/or non-routine projects requiring extensive knowledge of analytical technique, interpretation of methods not clearly defined and scientific decisions.
  • Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness.
  • Determine whether lab staff effectively validated methods and communicate any concerns or issues relating to same.
  • Prepares QC statements noting deficiencies with the analytical data set or notebooks.
  • Reports deficiencies to the project leader for correction.
  • Trains new QC Reviewers and laboratory staff. Performs other duties as assigned, including SOP review and writing.
  • Conducts consultations for quality records.
  • Assists the QC Supervisor in the evaluation of laboratory QC data review program
  • Maintain compliance and assist in continuous improvement of lab processes
 

Qualifications

Education and experience
  • BSc in Science or related field required
  • 4 years of QA/QC experience required (gaining thorough knowledge of chromatography)
  • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
  • Strong verbal and written communication skills
  • Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
  • Ability to independently review laboratory reports and analytical methods
  • Strong attention to detail
  • Ability to provide clear and concise feedback and/or documentation of results
In return you can expect career to work in a growing and dynamic environment. We look forward to your application.   #LI-MH1 PPDEMEA

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