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Details

Manufacturing Specialist


Reference:PORAVFG-472853p Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Executive


The Role

A Manufacturing Specialist is required to join a leading pharmaceutical organisation based in Dublin. With minimal supervision, you will support the execution of manufacturing/quality systems such as non-conformances, CAPA’s, change controls, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Responsibilities

  • Ensure that all Non-conformances are triaged within the established goal.
  • Responsible for authoring investigation reports and executing corrective actions
  • Monitor and communicate incidents trends.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.
  • Initiate, revise, and approve manufacturing procedures.
  • Ensure all procedures reflect current operations.
  • Assess process performance by observation of floor operations and review of performance data.
  • Evaluate, plan, and implement solutions for process improvement opportunities.
  • Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
  • New Product Introductions & Process or Equipment Modifications
  • Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

The Person




  • B.A. /B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.
  • 5 years’ related experience within a pharmaceutical organisation
  • Detailed technical understanding of bioprocessing unit operations.
  • Skilled in performance of GMP production operations
  • Regulatory knowledge and interactions
  • Participate and help lead cross-functional teams
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Organizational, technical writing and presentation skills.



If you would like further Information you can contact the recruiter directly:



Paula O'Reilly | Tel: +353 (0) 1 507 9265