Specialist Quality Assurance
SIRE Life Sciences®
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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 Noord-Brabant Netherlands.
The CompanyThe mission of this company is to help patients. Every day they fully commit to better the life of sick people. With a focus on results of the treatment they do scientific research, development and creating the most effective medication.
Role DescriptionAs a Specialist Quality Assurance you will work within the Quality Regional Work cell in Europe reporting to the Senior Manager QA. Understanding and grasping a wide range of quality related competencies while providing high complexity tactical support to the Site leads across multiple Quality Systems and Processes. In addition to the Quality Assurance duties you may be assigned specific oversight and responsibilities for key processes improvements within the department.
Responsibilities- Manage and own NC, CAPA, Change Control records for External Quality
- manage and drive Quality records to closure independently
- Perform Batch disposition activities in support of lot release
- Perform Continuous Improvements
- Demonstrate ownership for required training on Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints e.g.)
Requirements- Bachelor's degree in a Scientific Field
- Minimal 4 years' of experience in Quality and Manufacturing
- Extensive GMP Experience
- Ability to oversee multiple project, manage workload and timelines
- Understanding of the applicable Manufacturing/Testing Processes (Drug Substance, Drug Product, Packaging, Device Manufacturing processes)
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.