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Validation Specialist

Abeer Ansari
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Job Reference: JO-2006-65255_1592908021


This position provides SME support and management of C&Q and validation activities on projects at their Cork site to assist internal stakeholders to meet current cGMP regulatory requirements and Company procedures as per HPRA expectations.


  • Maintain and improve the commissioning, qualification, and validation systems within the company.

  • Assist with risk assessments/change controls and deviations by providing input as a subject matter expert on behalf of validation.

  • To lead and advise the validation of new/existing facilities, utilities, equipment, and processes and liaise cross-functionally on qualification & validation scheduling.

  • To review and evaluate FAT/SAT/FS/URS/SDS/HDS documents and reports to ensure a good design basis is established for all validation studies.

  • Generate, review, or execution of VMP/DQ/FQ/IQ/OQ/PQ/CV protocols/reports for equipment, facility, utility, process & computerised systems.

  • Create/maintain the site validation master plan or validation project plans when necessary.

  • Manage external contractors in accomplishing validation project tasks when required.

  • Create/maintain validation/engineering department related SOPs and WI documents.

  • Implement and complete engineering/validation related CAPA and deviation actions.

  • Use site Quality Management System software.

  • Maintain knowledge of current validation cGMP practices as per HPRA and EMA.

  • Implementation of the Cleaning Validation program within the company

  • Implementation and coordination of the annual re-qualification studies i.e. temperature mapping or air quality testing executed by external contractors.


  • Minimum qualification of a bachelor's degree in a scientific/technical discipline required

  • 3-5 years' experience working with validation and qualification projects within GMP regulated environments.

  • Experience in contributing to GMP management systems such as change control/deviations/risk assessments.

  • Understanding of various validation concepts i.e. thermal/sterilization/facility/cleaning/equipment etc.

  • Strong understanding of API manufacturing.

  • Experience working across a Global business a distinct advantage.

  • Skilled in the execution of Risk Assessment and the use of a variety of problem-solving techniques

  • Experience in projects, audits & inspections as Validation SME.

  • LEAN and Six Sigma philosophy are embedded in your day to day working.

  • Enjoy working closely with your stakeholders and have a hands-on operational approach to Validation.

  • A good communicator and when collaborating on a given task you contribute with a positive and constructive attitude.

  • Work independently with a strong personal drive.

  • Strong attention to detail and organisational skills with a quality-focused mindset.

  • Could critically assess issues and devise and execute appropriate solutions by decisively using problem-solving techniques.

  • Strong business mindset.

  • Travel may be required as part of the role.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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