QA Manager (CVS)
Location: GermanySIRE 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 Rheinland-Pfalz Germany.
Our client is one of the leading companies in the pharmaceutical industry with the focus on the development, research and manufacturing of new medications for therapeutic solutions. At the moment they are looking for a Quality Assurance Manager (CSV) in Ingelheim.
ROLE DESCRIPTION
As a QA Manager for Computer System Validation are in compliance with the internal CSV framework and QM System, this includes Cloud Computing and mobile applications.
RESPONSIBILITIES
- processes supported by computerized systems, regarding GxP regulations
- contribution to the continuous improvement process for the CSV strategy and methodology of our global quality management system,
- finding solutions to contribute to deployment process
- The preparation, coordination and presentation of CSV processes within the area of responsibility in audits and authority inspections, (FDA/ ANVISA /EMEA)
- Manage CSV-related projects and subprojects within our internal CSV framework (that includes preparation and also execution of trainings related to our global quality management system
REQUIREMENTS
- Diploma or Master's degree in Engineering, Information Technology and/or Natural Sciences
- GxP background with at least 3 years’ experience focused on CSV and information technology
- good knowledge of external regulations, e.g. EU-GMP Guideline, current data integrity guidelines
- Being ableto translate business processes and GxP requirements into computerized system processes
- Excellent English skills
- open for travelling
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Patricia Oses Equiza.
