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NPI Process Specialist

  • Sector: Science & Pharma
  • Contact: Barry O'Brien
  • Contact Email:
  • Job Ref: 17775

NPI Process Specialist X3

An exciting opportunity for an experienced NPI Process Specialist to join a leading pharmaceutical company based in Waterford on a fixed-term contract (with great scope for extension).

Role Responsibilities:

  • Lead the New Product Introduction for NPI as appointed and ensure all new process are introduced in line with DFM & PUCC principles.

  • Attend & participate in the NPI Technical Review Boards for the Wellness / Oral Care Categories as required on behalf of the NPI Lead.

  • Support the quarterly R&D/Technical/GMS liaison meeting.

  • Ensure Technical Risk Assessments (TRA) are implemented in conjunction with R&D before NPDs are transferred to the site.

  • Ensure a Product Control Strategy is in place for all NPI before the product is transferred to the site.

  • Lead the implementation of the following site validation schedules in accordance with the QMS across all value streams:-

- Process Validation

- Transportation Validation

which are required to support NPI launches.

  • Drive the implementation of the Real Time Trending process for all NPI post initial lunch for the 1st 30 batches produced as appointed.

  • Ensure for each NPI appointed a performance review is implemented once 30 batches are produced and the Product Control Strategy is updated, based on the outputs of the initial 30 batch review.

  • Implementation Process Change Control processes in accordance with the QMS / site change control policy, based on the outputs of the initial 30 batch review as required.

Role Requirements:

Preferred but not a requirement:

  • Third Level qualification in an Engineering/Science Discipline.

  • 3- 5 years' experience in Technical / Validation Department.

  • 5-10 years' experience a Technical / Validation involving the introduction of new products.

  • Working Knowledge of Process Validation Requirements for new product introduction, new raw material introduction and process optimization changes.

For a confidential discussion and more information on the role, please contact Barry O'Brien.