Quality Manager
Location: BelgiumSIRE® 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 Vlaams-Brabant Belgium.
• Ensure that (new) regulations are implemented in the company
• All compliance issues including local quality systems in GMP and GDP and Regulatory matters (authorizations, supply…).
• Ensure the quality aspects through participation in cross-organisational projects, reporting systems and meetings (product maintenance, change
controls, deviations, complaints, recall, …)
• QA function with respect to external suppliers and partners directly connected to the manufacturing site (e.g. qualification, audits, quality agreements,
evaluation)
• To promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel
• You will implement correct written procedures, in conformity with the internal and international guidelines.
• You will guarantee that a good documentation system is in place.
• You will participate in solving different problems and support for corrective actions in the GxP areas.
• Organisation and performance of Quality Management Review.
• Organisation and performance of self-inspections in GxP relevant areas.
• You will report to the Global Operation Quality: Monthly reporting, inputs to annual report KPIs and Product recall reports.
• QA function with respect to external suppliers such as qualification, audits and quality agreements.
• You will provide help for the establishment of Quality Agreement with the clients partners.
• Act as expert in quality processes tracked in EQMS.
• Participate in the periodic review of the Quality Manual.
• Monthly reporting to Global
• Fluent in English and Dutch (both verbal and written), French is a plus
• Ability to work easily with digital platforms
• Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and
Regulatory Affairs.
• Experience in a pharmaceutical environment is required
• Decision making based on scientific aspect and risk evaluation
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
Within this exciting company, you will:• Ensure that (new) regulations are implemented in the company
• All compliance issues including local quality systems in GMP and GDP and Regulatory matters (authorizations, supply…).
• Ensure the quality aspects through participation in cross-organisational projects, reporting systems and meetings (product maintenance, change
controls, deviations, complaints, recall, …)
• QA function with respect to external suppliers and partners directly connected to the manufacturing site (e.g. qualification, audits, quality agreements,
evaluation)
• To promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel
Responsibilities
• You will prepare and review the documents linked to the implementation of the Quality Policy and the Quality Management System (SOPs, WI’s…).• You will implement correct written procedures, in conformity with the internal and international guidelines.
• You will guarantee that a good documentation system is in place.
• You will participate in solving different problems and support for corrective actions in the GxP areas.
• Organisation and performance of Quality Management Review.
• Organisation and performance of self-inspections in GxP relevant areas.
• You will report to the Global Operation Quality: Monthly reporting, inputs to annual report KPIs and Product recall reports.
• QA function with respect to external suppliers such as qualification, audits and quality agreements.
• You will provide help for the establishment of Quality Agreement with the clients partners.
• Act as expert in quality processes tracked in EQMS.
• Participate in the periodic review of the Quality Manual.
• Monthly reporting to Global
Requirements
• Experience as Quality Assurance Officer or Manager• Fluent in English and Dutch (both verbal and written), French is a plus
• Ability to work easily with digital platforms
• Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and
Regulatory Affairs.
• Experience in a pharmaceutical environment is required
• Decision making based on scientific aspect and risk evaluation
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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