QA Validation Specialist

  • Type: Permanent
  • Location: Limerick
  • Salary: Negotiable
  • Job Ref: CSS180119
  • Date Posted February 12, 2020

Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for a a QA Validation Specialist to join their team. This is a full time, permanent position offering an excellent salary and benefits package.
Main Responsibilities:

  • Generates, executes, reviews, and approves master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs
  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Initiates, reviews, edits and approves change control and SOPs
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Trains/advises less experienced Specialists and Technicians.
  • Assesses quality system documentation for completeness and accuracy, and dispositions documentation per SOPs.
  • Completion of CFR Part 11 Assessments.
  • Manages projects and prepares status reports.

Education and Experience:

  • Requires a BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required.
  • Ability to comprehend regulatory requirements and technical documentation
  • High level of emotional maturity and self-confidence
  • Working knowledge of Microsoft Office Suite and LIMs.
  • Familiarity with qualification requirements for QC laboratory equipment such as HPLC, pH meter, conductivity analyzer, balances.
  • Strong knowledge of cGMPs for biotechnology;
  • Excellent written and oral communication skills.

For more information on this position please call Lee-Ann on or apply online and a member of the Harmonics team will be in touch

More Details

For more information on this position please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch

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