SIRE Life Sciences®
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SIRE® 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 Slough United Kingdom.
The CompanyOur client is a Pharmaceutical company in the Slough area
Role DescriptionThe CSV Manager will act as an interface between IT and QA and report directly to the Head of Global IT. The main responsibility will be the management and the execution of a complex portfolio consisting of medium to large-scale computer systems validation activities. This individual will also be responsible for supervising a small team of local/regional CSV specialists and must work closely with the CSV manager located in the US to ensure group wide computer systems and IT infrastructure compliance according to 21 CFR Part11 and EU Annex11 regulations.
Responsibilities- Manage a small team of internal and external CSV specialists
- Manage and perform companies computer systems validation activities according to applicable SOP`s
- Act as liaison between IT and QA to ensure that all computerised systems are in accordance with 21 CFR Part11 and EU Annex11 regulations
- Work closely with the CSV manager US to ensure that CSV is done in a holistic as well as harmonised way
- Continuous improvement and further development of companies CSV procedures and strategy
- Act as single point of contact for all local issues related to CSV
Requirements- BS degree or equivalent in either IT, Chemistry or Biochemistry
- 7 years minimum experience in a GMP regulated environment, with proven track record of industry regulations (21 CFR Part11 and EU Annex11) and standards (GAMP) for computerised systems
- Ability to comprehend IT software and infrastructure requirements and the associated regulatory expectations
- Proven track record in the validation of complex database driven systems such as ERP (SAP), LINS, MES and QMS
- Proven track record in IT infrastructure and network qualifications
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.