QA Lead Biotech
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 Flevoland Netherlands.
- Maintain the quality management system
- Carrying out/responsible for internal audits to ensure compliance status and to communicate the progress of solutions to the CEO.
- Preparation for the root cause analysis in case of customer complaints.
- Training the personnel and building up the company towards a full valid GMP environment
- Trending of customer complaints
- Maintain communication with the QA department of suppliers.
- Hosting regulatory and customer audits.
- At least 4 years of experience in a GMP environment.
- Experience as quality lead in GMP environment is considered as highly recommended.
- Experience with internal and external audits.
- Knowledge of and practical experience with quality management systems.
- Excellent communication skills at various levels, both Dutch and English.
The Company
A Biotech company with a broad experience who provides services to pharmaceutical and biotech companies as well as universities. those services contain finding solutions for their research challenge and provide the highest quality for the clinical trials of our customers.Role Description
In this position you are responsible and have a central role in building up and implementing the quality management within the company. You are constantly alert for improvements with regard to quality performance and contribute to improvement projects.Responsibilities
- Create with the colleagues quality standards and SOP’s- Maintain the quality management system
- Carrying out/responsible for internal audits to ensure compliance status and to communicate the progress of solutions to the CEO.
- Preparation for the root cause analysis in case of customer complaints.
- Training the personnel and building up the company towards a full valid GMP environment
- Trending of customer complaints
- Maintain communication with the QA department of suppliers.
- Hosting regulatory and customer audits.
Requirements
- Higher level of education (Master) in Life Sciences or a related field.- At least 4 years of experience in a GMP environment.
- Experience as quality lead in GMP environment is considered as highly recommended.
- Experience with internal and external audits.
- Knowledge of and practical experience with quality management systems.
- Excellent communication skills at various levels, both Dutch and English.
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