QA Validation Specialist | Collins McNicholas

QA Validation Specialist

  • Reference: GY43592
  • Job Type: Permanent
  • Location: Limerick
  • Category: Bio-Pharmaceutical

As QA-Validation Specialist  you will be responsible for the development and execution of steam in place sterilization and sanitization of process equipment. Implementation of company policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.


  • Generates, executes, reviews, approves, master and completed qualification/validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • Prepares equipment for qualification studies, 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.
  • Day to day management and oversight of sterilization contract specialists.
  • Assesses quality system documentation for completeness and accuracy, and dispositions documentation per SOPs.
  • Manages projects and prepares status reports.

Skills, Experience and Qualifications:

  • Requires a BEng/BSc 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.
  • Extensive experience in Steam Sterilization of biopharmaceutical process equipment.
  • Strong knowledge of cGMPs for biotechnology.
  • Excellent written and oral communication skills.

For a confidential discussion and more information on the role/company email your CV to:

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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

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