RA / QA Officer
Location: NetherlandsSIRE 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 Biotechnology and Pharmaceutical organization, based in Groningen Netherlands.
Our client is a manufacturer of biopharmaceuticals who operates in Europe and abroad.
ROLE DESCRIPTION
The RA/ QA Officer reports directly to the site Quality Director and ensures that all development and manufacturing activities are compliant with the regulations of the international Health Authorities. Additionally, this position is strongly involved in developing strategies for Health Authority inspections.
RESPONSIBILITIES
- Directly engaged with Health Authorities inspections
- Regulatory intelligence on trends and expectations
- Develop and submit critical site regulatory documentation (e.g Site MasterFile)
- Assist with authoring of regulatory documents such as INDA, Biological Process deviations, complaints
- Risk & Impact assessment from a regulatory perspective
- Develop and maintain quality systems
- Support other auditing activities such as client or vendor audits
REQUIREMENTS
- Master degree in Biochemistry, Biotechnology or Pharmacy
- Industrial or academic certification (e.g. RAPS) in areas related to RA is preferred
- Understanding of regulatory responsibilities and requirements in manufacturing and disposition of APIs
- Strong communication skills in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Anja Paetel.
