(Senior) 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-Holland Netherlands.
- Batch documentation, release and batch record review
- Preparations for product disposition by QP
- Supervise the EU packaging and shipping process and monitor the product disposal
- Review and approval of deviations, Change Controls and CAPAs
- Handling of product complaints for EU
- Liaise with other manufacturing sites, supply chain, CMO’s, corporate quality and other quality groups to maintain global quality
- Implement and maintain GMP training system in EU
- Support and manage the inspection process
- 5+ years of quality or manufacturing experience in a Pharmaceutical, Biotech or Biologics organization
- Working knowledge and ability to apply GMPs in conformance to US and EU standards
- Excellent written and spoken English language skills (Dutch is a plus)
- Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
- Excellent MS Office skills
- Experience with and knowledge of Change Control practices, Deviations and CAPA, manufacturing processes, GMP, including GDP, SOPs and quality systems
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 a global company and leader in engineered T cell therapy.Role Description
You will work within the Quality team, supporting the new area of cancer immunotherapy. You assist in the development, implementation and maintenance of a quality system. With this you contribute to the commercial marketing of the cell therapy product in the EU.Responsibilities
- Receipt and disposition of incoming materials- Batch documentation, release and batch record review
- Preparations for product disposition by QP
- Supervise the EU packaging and shipping process and monitor the product disposal
- Review and approval of deviations, Change Controls and CAPAs
- Handling of product complaints for EU
- Liaise with other manufacturing sites, supply chain, CMO’s, corporate quality and other quality groups to maintain global quality
- Implement and maintain GMP training system in EU
- Support and manage the inspection process
Requirements
- BSc or MSc in biological sciences or related field- 5+ years of quality or manufacturing experience in a Pharmaceutical, Biotech or Biologics organization
- Working knowledge and ability to apply GMPs in conformance to US and EU standards
- Excellent written and spoken English language skills (Dutch is a plus)
- Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
- Excellent MS Office skills
- Experience with and knowledge of Change Control practices, Deviations and CAPA, manufacturing processes, GMP, including GDP, SOPs and quality systems
Other information
Our client is looking for someone who can start as soon as possible. This person needs to be an all-rounder and selfstarter who can operate without guidance and is able to work in a dynamic and diverse team.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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