Quality NPI Lead for Pharma & Medical Devices

PCI Pharma Services; Stamullen; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

PCI Pharma Services Ireland site seeks a Quality Product(s) Lead to manage the quality elements of New Product Introduction and large-scale programmes for a client with multiple projects. You will collaborate across sites and customers, ensuring regulatory compliance and effective risk management throughout the project lifecycle.

You will lead teams, coordinate with Programme Managers, and act as the main quality contact for customers, driving SIT and KPI reporting and ensuring cGMP adherence

Qualifications

• 5 years’ experience in Quality pharmaceutical or medical device role.
• EQF level 6 in a technical, engineering or a science subject.
• Master’s degree (or higher) in a technical, engineering or a science subject.
• Proficient utilisation of Excel, Word, PowerPoint, Project and Visio.

Responsabilités

• Ensure compliance with cGMP, corporate standards/PQS, site policies and regulatory requirements.
• Partner with customers/stakeholders to deliver on records within timelines.
• Lead cross functional teams to provide consultative support on quality issues.
• Ensure instructional documentation is up to date and supports efficient production.
• Travel on company business as required.

Connaissances

NPI quality governance

Medical device assembly

cGMP knowledge

Customer liaison

Quality team leadership

EU GMP / ISO for MD

Project coordination

Lean manufacturing

Formation

EQF level 6 in technical/science

Master’s degree in technical/science

Outils

Excel

Word

PowerPoint

Project

Visio

Description du poste

PCI Pharma Services Ireland site seeks a Quality Product(s) Lead to manage the quality elements of New Product Introduction and large-scale programmes for a client with multiple projects. You will collaborate across sites and customers, ensuring regulatory compliance and effective risk management throughout the project lifecycle.

You will lead teams, coordinate with Programme Managers, and act as the main quality contact for customers, driving SIT and KPI reporting and ensuring cGMP adherence