Materials Compliance Specialist

Description Overview

In this role you will complete activities relating to supplier quality management for Active Pharmaceutical Ingredients (APIs), excipients, primary contact and printed packaging components, purchased products and critical service providers. 

This is used to ensure suppliers consistently provide materials and services that meet the required standards by Perrigo, thereby allowing the site to maintain a state of Good Manufacturing Practice (GMP) and continuity to supply of medicinal products. 

You will also ensure that sampling, inspection and control of materials received into the site are conducted in compliance with GMP and based on sound scientific and statistical principles to enable cost effective provision of materials that comply with the specification.

Scope of the Role

• Assessing compliance and risk for both new and reformulated products, including assessments relating to Nitrosamines, Residual Solvents, and Elemental impurities.
• Working collaboratively with Supplier Quality, Procurement and the Quality Control laboratory to actively manage the risks associated with supply chain to ensure verification activities are focused in high-risk areas.
• Supporting the Quality Systems team with material compliance and risk management.
• Managing coordination of material compliance requirements with multiple suppliers, product registrations and in line with current GMP.
• Ensure all incoming material are aligned to product registrations.
• Defining suitable testing regimes.
• Conducting risk assessments to ensure suitability of sampling and testing regime.
• Undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.

Experience Required

• A detailed and in-depth knowledge of raw materials testing and sampling.
• A sound understanding of the principles of quality risk management.
• Expert knowledge of GMP, specifically around materials, supply chain and inspection.
• Ability to organise own work and track work of others to deliver results.
• Can identify clear solutions and a pathway to achieving them.
• Looks at alterative solutions, excellent critical thinking skills.
• Places the customer and stake holders needs at the centre of work.
• Uses scientific data and analysis to come to decisions thinks clearly and is decisive.