Quality Assurance & Quality Control Expert
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 Cambridgeshire United Kingdom.
- Execute guidelines and Regulatory cGMP requirements in the respective Quality area
- Execute the implementation of facility projects in conformance to regulatory requirements
- Participate in GMP audits as required
- Act as Oversight Quality representative, to ensure quality system and quality documentation in respect to current guidelines, compliance and regulatory requirements.
- For change control, review and evaluate change requests according to processes, quality systems and applicable regulatory files to meet Corporate, Divisional and Regulatory requirements (incl. BLA, MAA files).
- Assess results in terms of acceptability to standards, procedures and regulatory requirements.
- Provide quality oversight in term of solving problems/root cause for deviation, CAPA and laboratory investigation.
- At least 7 years of experience in pharmaceutical or biotechnological companies in the Quality department.
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 global Pharmaceutical company based in CambridgeshireRole Description
Quality Assurance & Quality Control ExpertResponsibilities
- Provide Quality Oversight to the main partners on site and for partners such as Quality Control- Execute guidelines and Regulatory cGMP requirements in the respective Quality area
- Execute the implementation of facility projects in conformance to regulatory requirements
- Participate in GMP audits as required
- Act as Oversight Quality representative, to ensure quality system and quality documentation in respect to current guidelines, compliance and regulatory requirements.
- For change control, review and evaluate change requests according to processes, quality systems and applicable regulatory files to meet Corporate, Divisional and Regulatory requirements (incl. BLA, MAA files).
- Assess results in terms of acceptability to standards, procedures and regulatory requirements.
- Provide quality oversight in term of solving problems/root cause for deviation, CAPA and laboratory investigation.
Requirements
- University degree in Engineering, Biotechnology; Pharmacy; or Quality Management applied to industrial process- At least 7 years of experience in pharmaceutical or biotechnological companies in the Quality department.
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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