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External Manufacturing Specialist

Reference:POR832252 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist

An External Manufacturing Specialist is required to join a leading global Biopharmaceutical organisation in Limerick. The External Manufacturing Specialist oversees all aspects of drug product contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.

The Role

  • Serves as an operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
  • Coordinates DP manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities, and enlisting support from others who will provide any required associated reports and technical expertise.
  • Liaison between various departments including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
  • Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
  • Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers and business partners.
  • Ability to travel up to 25% (domestic and international).

The Person

  • Requires a BS/BA in a scientific, or engineering discipline
  • 3+ years’ experience of working in a GMP environment with a focus on CMOs
  • Working knowledge of industry practices and regulations (e.g. GxP, FDA regulations), familiarity with ICH guidelines and EU regulations.
  • Proficient in, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments.
  • Knowledge of drug product manufacturing from formulation through the final package is preferred
  • Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
  • Fluent in English with a preference given to candidates with competencies in German and/or French (oral and written).

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

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