Qualified Person (Third Party & NPI)
Job Title: Qualified Person (Third Party & NPI)
Work Pattern: 38.75 work hours (Mon – Fri)
Reporting to: Quality Director
Responsible for (staff): N/A
This role sits within our site Quality Team, reporting to the Quality Director. Lead QP for the release of Third-Party products at PCI Dublin. Sterile experience required with biotechnology QP release experience ideal. 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.
Essential Duties and Responsibilities:
- QP release of Third-Party products and ensuring associated activities supporting release are in place.
- Ensuring that the required checks/systems are in place with contract CMO/CRO and MAH to support release.
- Provide QP Declarations, review approve, analytical, microbial and operational investigations from Third Party Manufacturers and assess the impact to batch certification.
- 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.
- 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.
- 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.
- 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 for the site Quality Management team.
- 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.
- 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 Behaviors.
- Previous QP releasing experience.
- Sterile / Biotechnology background.
- NPI and onboarding of new products.
- Strong experience in Pharmaceutical Project Management.
- Sound working knowledge of cGMP and GAMP.
- Qualified Person Accreditation.
- Prince 2 (or equivalent) project management qualification.
- Proficient utilisation of software packages such as excel, word, PowerPoint, project and Visio and a high level of computer literacy.