Npi Quality Lead, Stamullen

Last update 2023-12-02
Expires 2024-01-02
ID #1922014846
Npi Quality Lead, Stamullen
Ireland, Louth, Stamullen,
Modified November 13, 2023


Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.We are now looking for a NPI Quality Lead (Permanent role) to join our team in City North, Ireland.Main purpose of job:Responsible for all Quality and Regulatory aspects for commercial packaging projects managed by the New Product Introduction (NPI) team across the PCI Pharma Services (PCI) Dublin sites including but not limited to:Support the generation of quotations for new business, established product updates and new SKU extensions in line with the standard EU ways of working.Management of all NPI Quality & Regulatory associated tasks to site ensuring integration into all site wide business units and to own the project until formally handed over and embedded into the commercial phase in line with the standard EU ways of working.Support the annual review of all SKU’s to ensure process is still fit for purpose and meets the agreed costing and margin in line with the standard EU ways of working.Driving and embedding a ‘One PCI’ culture, brand and message.Main responsibilities:Provide a Quality and Regulatory Function to the NPI Business Unit (BU) infrastructure to support the site operational, commercial and business development functions.Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP, technical standards, procedures and systems.Development, maintenance and standardisation of the EU NPI Quality ways of working including but not limited to databases, specifications, templates, SOP’s and training while ensuring compliance with non- NPI project / routine business ways of working.Key member of NPI project teams providing guidance to customers on Quality and Regulatory aspects relating to product importation, testing, and release.Preparation of regulatory submissions as deemed necessary via the NPI on-boarding process to appropriate health authority. As needed, identifying requirement to audit, arranging and/or performing Quality audits necessary to support introduction of new products to PCI sites.Generation, review and approval of Quality/Technical agreement documents which are derived through the NPI process.As part of the wider Site Quality team, perform tasks, as necessary, which may be needed relating to Quality, Regulatory and Compliance matter affecting the site. This may include making regulatory submissions perfuming risk assessments or helping with non-conformances for example.Review and approval of NPI Project documentation to include Validation Protocols & Reports, Change Controls, SOPs (new and modified) and Batch Packaging Records (BPRs).Preparation of the monthly and/or quarterly Quality report the site Quality Management team.Timely raising of Capital Expenditure Requests (CER) relating to the specific NPI in order to deliver the NPI on time in full and to budget.Monitoring, controlling and reporting of the Quality elements of the NPI CER budget and or on-boarding costs incurred including but not limited to travel and expenses.Working with customers and suppliers to ensure that new products are introduced on time, in full, to cost and too applicable standards.Provide internal & external customer and supplier appropriate NPI status reporting including but not limited to Issue and Risks, Budget control, performance and schedule adherence.Working in conjunction with Procurement to identify preferred suppliers to fulfil the needs of the NPI.In conjunction with the operational group participate in Continuous Improvement Projects, product and process reviews to resolve operational performance and functional issues, as required, to ensure improved efficiencies, reduced waste and cost.In conjunction with the operational group assist in technical, product and process reviews to resolve operational, performance and functional issues.Drive a Right First-Time culture within operations to deliver a Zero Defect performance.Deliver products of value at Optimal Cost.Build, develop and sustain the knowledge, capability and competency with the NPI team to support ongoing and changing technologies employed to meet the business objectives.Monitoring of future technologies and market trends identifying areas for potential investment including reporting and recommendations to senior and executive members of PCI.Create and sustain a working environment that promotes the PCI Values and Behaviours.To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.Scope and Authority:The job holder is responsible for adhering to SOPs, Health & Safety, GMP and other regulatory guidelines themselves and by team members. The job holder may have indirect people management responsibilities for their NPI sub project team members and ensuring that all KPIs, targets and any other deadlines are met individually and by the team. This position has authority for expenditure as defined in the purchasing authority levels document.#LI-VR1Join us and be part of building the bridge between life changing therapies and patients.

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Npi quality lead

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