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Job Details

QC Data Reviewers-143953

Company: PPD
Location: Europe, Middle East & Africa-Ireland-Westmeath-Ath
Reference: 143953
Closing Date: 13 Jan 19
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

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. ...

Requirements:

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 highly qualified GMP lab staff work with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.

We are currently seeking QC Data Reviewers 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 sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
  • Communicates with laboratory staff to proactively address the quality of laboratory documentation.
  • 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.

Qualifications

Education and experience
  • BSc in Science or related field required
  • QA/QC experience required (gaining thorough knowledge of chromatography)

We have a varying levels of positions open so open to candidates with 1 - 4 years experience.

  • 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.  

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Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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