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.