QA Specialist
Location: NetherlandsSIRE® 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 Noord-Brabant Netherlands.
- Provide tactical information to the networks (metrics to management, data
analysis, trending, periodic monitoring, APR)
- Riskmanagement
- Training on required Quality Systems (NCMS, CCMS, LIMS, SAP and Complaints)
- Improvement initiatives within the Regional work cell and the wider organisation
- Manage Regional Work Cell activities including Visual management, level loading, capacity & capability management
- 4+ years of quality or manufacturing experience in a Pharmaceutical or Biotech industry
- GMP experience
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
- Yellow or Green belt
- English communication skills (Dutch is a plus)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
The Company
They are committed to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.Role Description
The QA Specialist will be required to understand a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes.Responsibilities
- Manage and own NC records, CAPA, Change Control, Quality records, batch disposition and release activities- Provide tactical information to the networks (metrics to management, data
analysis, trending, periodic monitoring, APR)
- Riskmanagement
- Training on required Quality Systems (NCMS, CCMS, LIMS, SAP and Complaints)
- Improvement initiatives within the Regional work cell and the wider organisation
- Manage Regional Work Cell activities including Visual management, level loading, capacity & capability management
Requirements
- BSc or MSc in biological sciences or related field- 4+ years of quality or manufacturing experience in a Pharmaceutical or Biotech industry
- GMP experience
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
- Yellow or Green belt
- English communication skills (Dutch is a plus)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
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