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

Apply for this job

    Your Name (required)

    Your Email (required)

    Your Message

    Job Ref. Number (see top of page)

    Attach Your CV
    (.pdf, .doc or .docx format)

    captcha
    Enter the above security code