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).
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.
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.