QA Associate | 6 months

Location: Netherlands

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 organisation, based in Zuid-Holland Netherlands.

The Company

This company is world leader in developing and producing vaccines. The Quality Assurance department within this company sees to that quality systems are applied as per GMP standards and is responsible for handling non-conformances, bulk and intermediate release and change control. The department plays an important role in providing advice on quality topics to all departments, which are part of the supply chain. They are looking for an enthusiastic and driven new colleague who can take up this challenging role as QA Associate. A good opportunity to get to know this company!

Role Description

In the position as QA associate you are the quality expert who monitors and improves the quality of their production and quality systems in a constructive manner, together with all the supply chain departments. You are the first contact person for all departments with regards to quality issues and you work together with the subject matter experts of these departments. This position will be in the New Product Introduction branch.

Responsibilities

- Assess and review the outcome of the initial investigation and the proposed corrections.
- Asses and oversee the quality of related documentation
- Be a part of the investigation teams and monitor the quality of the Root Cause investigations, assessing potential consequences of non-conformances on the quality of the products
- Review and sign of investigation related reports, responsibility for the closure of the Quality Investigations and CPA records in TrackWise
- Participation in (Global) escalations of issues, which have (potential) impact on the delivery of product to the patients
- Participation in risk assessments as applicable
- Actively involved in initiatives that lead to higher quality and compliance awareness for the people on the shopfloor
- Align and agree on improvement actions with the departmental subject matter expert and you follow up on the agreed solutions
- Outside office hours you act as QA representative on a rotation basis with colleagues and you can be reach by the pager or business mobile phone
- Approve change notices (procedures) in name of QA and handle change controls in relation to Cost Per Action (CPA)
- Participation in New Product Introduction (NPI), Quality and Capacity projects

Requirements

- Minimal HBO in Biochemistry, Biology or a Pharmaceutical degree
- 5-7 years' of relevant working experience in a GMP environment
- Great sense for quality and excellent analytical abilities
- Fluent in English in word and in writing
- Strong communication skills

Other information

They are looking for somebody who can make well motivated decisions on their own, experience in the following is a plus:
- Data analytics
- Vaccines
- New Product Introduction
- Process Excellence
- Co Think
- Kepner-Tregoe
- Dutch

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