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Details

Manufacturing Specialist


Reference:PORAVFG-472853p Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Executive

A Manufacturing Specialist is required to join a leading biopharmaceuticalorganisation based in Dublin on a 12 month contract. With minimal supervision you will ensure development, implementation and maintenance of a robust Aseptic Compliance program. Responsibilities will also include supporting the execution of manufacturing/quality systems such as non-conformances, CAPAs, 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.

Responsibilities

  • Ensure a strong regulatory reputation in Aseptic Compliance is maintained
  • Prepare the site for successful inspections, both external and corporate
  • Ensure constant inspection readiness status by engaging actively with the Microbiology Laboratory, Manufacturing areas and other classified areas and ensure any corrective or preventive actions are in place and addressed in a timely and accurate manner.
  • Ensure site compliance with Operating Standards & regulatory requirements specifically for aseptic manufacture.
  • Execution of aseptic compliance audits
  • Provide input as key Subject Matter Expert into significant investigations on site.
  • Take a lead role in design and qualification process of new aseptic manufacturing and support areas.
  • Ensure that all Non-conformances are triaged within the established goal.
  • Responsible for authoring investigation reports.
  • Responsible for execution of corrective actions.
  • Responsible for managing NC/CAPA closure


The Person




  • B.A./B.S. in Biology/Life Science/Engineering
  • 10 years’ related experience within a pharmaceutical organisation
  • Detailed technical understanding of bioprocessing unit operations.
  • Skilled in performance of GMP production operations
  • Strong Aseptic Compliance knowledge and experience



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



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