QA Officer cGMP Batch Review | 6 month project | Leiden

Bedrijfsnaam: -
Plaatsingsdatum: 08/02/2019
Standplaats: -


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 Zuid-Holland Netherlands.The CompanyJanssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases. In our organization entrepreneurial people work in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.

Role DescriptionYou will support production from "the outside"; e.g. on documentation review and update, and handling escalations. This job does not involve hands-on execution, however you will be visiting production and support the operators.

Responsibilities- Taking part in activities related to the production of cGMP batches. This includes processes such as batch record review and taking escalations from cell and virus culture, purification processes, formulation & fill and in-process testing.
- Accurately completion of documentation such as batch records, logbooks, etc.
- Working precisely, detecting and solving acute problems and communicate possible abnormalities.
- Actively participating in setting up documentation to ensure successful production runs.
- Responsible as area owner that the production areas are according EHSS and compliance standards.
- Internal organization of the facility, including ISL, 5S and kanban systems.
- Involvement in deviation investigation and follow up.
- Write training documentation and perform training of new operators.

Requirements- Bachelor or Master level or equivalent
- 2-6 years’ experience in a biotechnology or biopharmaceutical industry environment.
- GMP experience, either in the pharma or medical device sector

Other informationThis is a maternity leave backfill combined with an addition sought based on current workload, so options to extend are not immediately evident, but in case of strong performance and continued workload, there may be a possibility to extend.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
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