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Technical Writer (GMP Documentation)

time Online sinds 7 november 2023 - Vaste jobs
The Technical Writer will provide oversight of all GMP documents and ensure that all documents are updated and effective in alignment with the needs of CAR T Operations and document lifecycle management.They will also be responsible to prescribe the correct training based on the type of changes made.Major Responsibilities:Oversight of the revision process of existing SOPs in time to support Manufacturing Strategy.Oversight of the introduction of new SOPs in time to support Manufacturing Strategy.Ensure Master Batch Record changes are made in time to support Manufacturing Strategy.Ensure proper training is prescribed as per the document changes made.Liaison with Operations, Technical Operations and QA to ensure alignment of changes.Continuous improvement of all GMP documents to ensure they are streamlined and robust, easy to use and intuitive; to help ensure maximum prevention of operational errors and quick turnaround times.Stay current regarding industry standards and ensure that all GMP documents are cutting edge and incorporate all latest regulatory and quality requirements.Support development and roll out of an electronic batch record.Track relevant KPIs.Ensure periodic log book reviews are complete.Ensure periodic review of all GMP documents are completed on time.Company:Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions.