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.