Quality Assurance 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 organisation, based in Noord-Holland Netherlands.
During inspections or other critical incidents, requests documents and/or actions which need to be delivered and validated by others.
Assist in the good documentation and monitoring of deviations, product complaints and events (process deviations, product technical events, distribution errors, damages and returns) conform current GxP guidelines (Good Distribution Practice, Good Manufacturing Practice);
Support site implementation and maintenance of the controlled QMS document system;
Checks the CAPA and Change Control Requests for completeness and follow up any missing information as necessary;
Maintains the CAPA and Change Control databases and follows up on outstanding CAPA and Change Control plans;
Review and evaluate Global Temperature Excursion events ensuring that a Quality recommendation on product disposition is provided based on review of shipping documentation and event details versus available product stability data;
Bachelor level education or equivalent;
Must be able to work independently and to strict timelines.
Fluency in English;
Demonstrate an understanding of the Quality environment (i.e. through an internship, studies or previous work experience);
Accuracy and an eye for detail;
Ability to prioritize and cope with conflicting pressures and priorities;
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Seppe Verhoeven.
The Company
.Role Description
Your main responsibility will be to the administration of the Quality Systemas well as supporting overall Quality Assurance and GxP Compliance.Responsibilities
Support Quality Systems and documentations (Document control, Deviations, Corrective and Preventative Action (CAPA), Complaints, Change Controls and Quality Agreements);During inspections or other critical incidents, requests documents and/or actions which need to be delivered and validated by others.
Assist in the good documentation and monitoring of deviations, product complaints and events (process deviations, product technical events, distribution errors, damages and returns) conform current GxP guidelines (Good Distribution Practice, Good Manufacturing Practice);
Support site implementation and maintenance of the controlled QMS document system;
Checks the CAPA and Change Control Requests for completeness and follow up any missing information as necessary;
Maintains the CAPA and Change Control databases and follows up on outstanding CAPA and Change Control plans;
Review and evaluate Global Temperature Excursion events ensuring that a Quality recommendation on product disposition is provided based on review of shipping documentation and event details versus available product stability data;
Requirements
Team player and to be able to work with several disciplines in a multicultural setting;Bachelor level education or equivalent;
Must be able to work independently and to strict timelines.
Fluency in English;
Demonstrate an understanding of the Quality environment (i.e. through an internship, studies or previous work experience);
Accuracy and an eye for detail;
Ability to prioritize and cope with conflicting pressures and priorities;
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Seppe Verhoeven.
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