QA Officer (one year)
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Noord-Holland Netherlands.
Internationale, pharmaceutical client who is committed to the develop medicines and in this way improve a patient life.
ROLE DESCRIPTION
In this role you are responsible for the evaluation of all documentation that are required for batch release for the Qualified Person (QP). This documentation may consist of production documents, QC analytical documents, QC Microbiology documents.
RESPONSIBILITIES
- Review batch records;
- Check GMP guidelines are being used the right way;
- Check completeness and accuracy of all batch documents and analysis results;
- Review of data;
- Check for proper sampling of raw materials, in accordance with documented timetable schedules;
- Summarize (critical) deviations in the documentation for QP release;
- Discuss with the QA Manager Review and QP's departments the priority and details of batches to be released;
- Set priorities in the absence of QA Manager.
REQUIREMENTS
• Completed HBO/WO Master in Life Sciences;
• Some work experience (1 y+) In a pharmaceutical company or related industry;
• Knowledge of pharmaceutical production processes (GMP, GDP)
• Good command of the English language in word and writing
• Understanding of production processes and business processes
• Good communicative skills
• Accuracy, initiative, alert, decisive and flexible
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
