- Reference: CJ44713
- Job Type: Contract
- Location: Munster, Waterford
- Category: Science, Pharmaceutical & Food
- Be accountable for NPI initiates as appointed
- Lead the implementation of NPI initiates as appointed at the company and to ensure all New Product Introductions are developed in accordance with the principles of DFM & PUCC such that all NPD which are transferred from R&D to the site are robust and capable processes which meet the Quality and Compliance standards required by the company/IMB/FDA and other major regulatory bodies.
- Lead the introduction of New Technology Platforms to support the site operational model as appointed
- Lead the introduction of New Product families as per the site strategy
- 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 acquired 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: –
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.
- Lead the introduction of New Technology Platforms to support the site operating model as appointed
- Lead the introduction of New Product families into the site as appointed.
- Support Operational Excellence initiatives as part of each NPI introduction as identified
- Support Site Procurement initiatives as part of each NPI introduction as identified
- Support the introduction of all Raw Material / Packaging changes associated with NPIs are fit for purpose prior before being formally commercialized and are introduced in accordance with the QMS / site change control policy
- Drive Raw Material Source Changes for established product as identified
- In conjunction with the NPI lead identify NPI training needs and ensure training plans are put in place to address these needs.
- In conjunction with the NPI lead ensure development plans are in place for NPI role.
- Integrate Technical NPI standards into site business plans and activities.
- Review & update all Technical NPI documents in accordance with the QMS
- Monitor and control Technical NPI expenditure each NPI being implemented to ensure the NPI remains within the agreed budget.
- Feed into of the Process Prioritisation listing to ensure all functions have appropriate visibility of timelines for NPI activities from both an operational capacity requirements / support resource requirements (QC/Reg/etc.)
- Support site monthly Technical Review meeting in conjunction with the Technical Process Manager & the Technical Automation/Equipment Validation manager
- Support the weekly Technical NPI/Raw Material Source Changes Team Meetings
- Support the site Problem Solving Process as required
- Attend key site plant meetings as identified
- Impact of role on business objectives This role operates at Grade 8. The role needs to support and positively impact site business objectives in relation to new product introduction, raw material source changes, procurement initiatives, waste and process BRFT for new processes.
Qualifications & Experience
- 2+ years’ experience working in a Technical / NPI process in a Solid Dose/Transdermal/Paste technology based industry.
- Working Knowledge of NPI / Raw Material Source Changes Packaging / Validation Requirements, HR Systems and People Management
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email firstname.lastname@example.org
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