SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Cambridgeshire United Kingdom.

The Company

Our client is a global Biotech company based in Cambridgeshire

Role Description

QA Expert Supplier

Responsibilities

- Responsible for qualification of suppliers. (on-site audits, negotiations, maintain approved supplier database, life cycle management of materials.
- Problem solving tools and methods leading investigations (e.g. CAPA, SCARs) for issues with material or services of suppliers
- Responsible for review and approval of changes to documents, databases related to Materials and Supplier;
- Work closely with Manufacturing, Purchasing and other departments within Quality to ensure compliance to quality systems;
- Serves as subject matter expert for Raw Materials in areas of expertise;
- Able to act as Subject Matter Expert during inspections and audits for the areas of responsibility;
- Lead and execute continuous improvement projects
- Serve as Supplier Quality representative
- Responsible for resolving issues related to Supplier’s processes;

Requirements

- Bachelor’s degree in Sciences or Engineering (Biomedical, Chemical, Mechanical or Materials Science discipline);
- 4 to 10 years’ experience in quality operations within a biotechnology, biologics, or pharmaceutical manufacturing company/field.
- Strong knowledge of FDA, EMA, UK regulations & Quality system’s related standards: 21CFR210/211, EU Guide Vol 4, industry related guidance’s;
- Strong Experience with Materials and Supplier Management processes;
- Experience with inspection and audit processes - auditor qualification would be a plus;
- Able to investigate using statistical tools, to plan and implement solutions to technical problems;
- Self-motivated, able to exercise sound judgement in resolving appropriately

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.