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Posted On:

Apr 26 2012



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At Pharma-Bio Serv we are hiring two Snr Software Testers for a project team in Limerick. This is a 9 month contract role, working as our consultant on site.

  • Prioritize qualification activities in line with the project schedules and business needs.
  • Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements
  • Execute qualification protocols as required including risk assessments and regulatory reviews.
  • Resolve and assist in the closure of deviations initiated during qualification execution.
  • Complete 21 CFR Part 11 and Annex 11 Assessments - experience of CFR Part 11 & CSV would be an advantage but not essential.
  • Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
  • Implementation and co-ordination of the change control process, review change controls for validation impact, promotes timely approval of all supporting documentation.
  • Generate SOP’s / other documentation as applicable.
  • Validation representative at daily project management meetings, weekly change control and team meetings.
  • Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process / product introductions.
  • Identification and root cause analysis of potential bugs.
  • Participate in Troubleshooting.
  • Manage defects through a defect tracking system.
  • Work with the various departments / groups in development and execution of validation activities associated with new system or System upgrades.
  • Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
  • Proven track record in development / execution of Validation programs in areas of Systems
  • Run / Manage complaint investigation and resolution of same.


  • A minimum of 3-4 years testing experience in an Oracle/ Web based environment/ Microsoft SQL, preferably in the healthcare industry.
  • Strong knowledge of CSV/GAMP, 21CFR Part 11, Annex 11, Project Life Cycle and cGMP Regulations,
  • Working knowledge of development and test life cycles.
  • Firm sense of accountability, ownership for end-to-end project lifecycle and sound knowledge of project management.
  • Good knowledge of statistical techniques in the use of problem solving / data analysis.
  • Outstanding verbal and written communication and presenting skills with the ability to interact with technical and non-technical groups.
  • Adaptable and flexible
  • Ability to demonstrate standards of leadership - managing complexity / Credo values / Innovations / Customer Focus Flexible Team Player Good influencing skills.

Pharma-Bio Serv is a Regulatory Compliance and Validation Consulting Service provider, with locations in Cork Ireland, Philadelphia, USA and Puerto Rico. Over the past 19 years, we have established a broad base of compliance related services, currently focused on the effective and optimized leveraging of Quality Risk Management Strategies. Our goal is to provide our partners with insightful and robust compliance solutions, that have a direct impact on your business.

For more information on the above role please contact Ruth Scanlan on 021-4619034 or 086-7952012.