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O'Neill & Brennan
Unit 2, Ballymount Business Park,
Lower Ballymount Road, Dublin 2
Tel: +353 (0)14 569 899
E-mail: dublin@oandbgroup.com
Web: www.oneillandbrennan.com

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Quality Control Specialist - Dublin (1469)

Location: Dublin
Entered: 28 Mar 2017
Salary: Market related
Duration: Permanent
 



















Our client is eagerly seeking a QA Specialist to join their growing team. 

 

Job Responsibilities


  • Support all activities involved for the transfer, validation and qualification of test methods and processes.
  • Write/review and approve analytical gap assessments, protocols, reports for validation/transfer activities.
  • Support statistical approach to setting of acceptance criteria for validation/transfer.
  • Support Annual Product Quality Review for validation.
  • Support regulatory filing submissions for new products.
  • Assist in the preparation and review of area documentation e.g. SOP's and Forms 
  • Support statistical approach to setting of acceptance criteria for validation/transfer.
  • Support the project management for the introduction of new products.
  • Write/review technical transfer deviations.
  • Troubleshoot laboratory methods and instrument problems.
  • Liaise with all customers both internal and external.
  • Facilitate training of analysts on new technologies.
  • Report project updates to the QC lead.
  • Perform and assist in additional duties as directed by the QC Lead.
  • Support Laboratory inspection and audits


Core Competencies


  • Experience with technical elements of the analytical method validation and transfer process.
  • Experience with Lab systems an advantage. (LIMS, CDAS, QTS, PDOCs).
  • Proven success in proactive project management.
  • Experience is managing multiple projects and reporting regularly to management and senior management within the organisation.
  • Proven expertise and technical competence.
  • Proven ability to communicate problems and required resolution in a positive and proactive manner.
  • Proven ability to recognise problems with equipment, methods, software, procedures and resolve the issues.
  • Self-directed, self-motivated with a demonstrated record in project accountability.
  • Proven knowledge in analytical techniques, analytical instrumentation theory and practice.
  • Excellent communications skills

Educational background


  • B.Sc. degree in chemical sciences, or other related technical degree or equivalent experience in regulated industry.
  • 5+ years working within quality control environment, with a minimum of 2 years on analytical validations and transfers. 

Please send your CV to Aoife at ireprotech@oandbgroup.com or call us on 01-4569899

 

 

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