QA/RA Senior Project Manager
Location: United KingdomSIRE® 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 Surrey United Kingdom.
- Facilitate communication between project teams and the experts in QA and RA as well as to the external customers. This includes the notification of quality events, answering of questions, and reporting results.
- Provide guidance to the project teams on CMC development.
- Facilitate decisions regarding cGMP-compliance together with the respective QA responsible.
- Review & approval of GMP documents related to the concerned development projects
o Manufacturing deviations
o Manufacturing changes
o API specifications and respective changes
o Documents related to process validation (protocols, reports, risk assessments, etc.)
- Good knowledge, preferably experience in the CMC development of APIs
- Experience in an GMP environment, good knowledge of GMPs
- Good project management skills
- QA experience or good knowledge of pharmaceutical quality assurances systems would be an asset
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.
The Company
Our client is a Pharma company in the Guildford areaRole Description
QA/RA Senior Project ManagerResponsibilities
- Represent QA/RA in interdisciplinary project teams for API CMC development- Facilitate communication between project teams and the experts in QA and RA as well as to the external customers. This includes the notification of quality events, answering of questions, and reporting results.
- Provide guidance to the project teams on CMC development.
- Facilitate decisions regarding cGMP-compliance together with the respective QA responsible.
- Review & approval of GMP documents related to the concerned development projects
o Manufacturing deviations
o Manufacturing changes
o API specifications and respective changes
o Documents related to process validation (protocols, reports, risk assessments, etc.)
Requirements
- Master in chemistry or pharmacy or closely related disciplines- Good knowledge, preferably experience in the CMC development of APIs
- Experience in an GMP environment, good knowledge of GMPs
- Good project management skills
- QA experience or good knowledge of pharmaceutical quality assurances systems would be an asset
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.
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