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Job Details

Associate/QC Reviewer-143953

Company: PPD
Location: Europe, Middle East & Africa-Ireland-Westmeath-Ath
Reference: 143953
Closing Date: 21 Jun 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD provides laboratory services that are designed to increase speed and precision. Our lab employees are committed to quality results and strict compliance with regulatory standards. Our Athlone GMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. ...

Requirements:

PPD provides laboratory services that are designed to increase speed and precision. Our lab employees are committed to quality results and strict compliance with regulatory standards.

Our Athlone GMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. 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 a 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.

  • Evaluates laboratory data for compliance with analytical methods and SOPs.
  • 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. Consults with supervisor regarding priority of assignments.
  • 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
  • 2 years of QA/QC experience required
  • Or an equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
  • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
  • Thorough knowledge of chromatography and divisional SOPs
  • Strong verbal and written communication skills
  • Ability to train staff
  • Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
  • Ability to independently review laboratory reports and analytical methods
  • Ability to deal with multiple and changing priorities
  • Strong attention to detail
  • Ability to provide clear and concise feedback and/or documentation of results

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Apply for this job: Associate/QC Reviewer-143953

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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