is a critical part of an innovative team that supports the company's drug discovery/development effort. Conceptualizes, develops, revises, and finalizes toxicology (GLP and non-GLP) study designs and reports; drafts nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., IB … DSUR, PSUR, etc.) to ensure regulatory compliance. Manages and monitors nonclinical studies (GLP and non-GLP) at external CROs per Jazz standards and ensures that global regulatory/compliance requirements are met/exceeded. Critically reviews and edits CRO nonclinical toxicology study reports, analyzes and interprets data, defines PK/… to synthesize and communicate complex information. Capacity to propose practical mitigation (de-risking) strategies. Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations. Required experience in authoring non-clinical elements of major regulatory submissions (INDs, CTAs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., IB more »
identification and quantification and HPLC - Assist with training and qualification of new QC Techs - Lead investigations of corrective actions or out of spec results - GLP Skills: Quality control, Laboratory, Chemistry, microbiology, Wet chemistry, Physical testing, Gmp, Titration, Viscosity, fda, glp Top Skills Details: Quality control,Laboratory,Chemistry,microbiology Additional Skills more »
that were ran overnight. They will be looking at backlogs and be assigned up to 10 assays. They will also: Adhere to GMP/GLP Conduct routine analyses independently and in compliance with applicable methods, protocols, SOP's and regulatory agency guidelines Document work and maintains study documentation and laboratory … review of data Plan assigned workload on a daily basis and effectively schedule multiple assignments Skills: UPLC, HPLC, pipetting, gmp, ph meter, wet chemistry, glp Top Skills Details: UPLC,HPLC,pipetting Additional Skills & Qualifications: Bachelor's Degree is Sciences (Chemistry, Biochemistry, Biology, etc.) preferred. Working in a lab setting - 6+ more »
Environmental Science or a similar scientific subject. Do you have 10+ years of experience in Residue Analysis Or Environmental Fate and Metabolism in a GLP-regulated laboratory? Have you also worked within a CRO company and are looking for a change? You could play a crucial role in various research … study protocols and applicable regulatory guidelines. Manage and oversee study activities including sample preparation, analysis, and data interpretation. Ensure compliance with study protocols, SOPs, GLP regulations, and other applicable guidelines. Manage project timelines and budgets. Conduct field residue, method development, method validation and analytical phases of ecotoxicological studies. Benefits: Competitive more »
to detail, strong organisational skills and ability to multitask. Keywords: Planner, service, equipment, coordinator, administrator, administration, planning, scheduler, CMMS, GMP. GLP, GXP, GDP, GoodLaboratoryPractice, Good Manufacturing Practice, Good Documentation Practices, Manchester, Northwest, Macclesfield. VRS8731MP. Follow VRS Recruitment on LinkedIn to view all our latest vacancies! Please note that more »
LIMS to Winpath Enterprise to align with the rest of SWLP network. Chemistry incorporates automation predicated on Abbott Alinity ci-series analysers connected to GLP track at St Helier and GLP task targeted automation at Epsom and manual section providing a wide array of esoteric assays. The appointee will support more »
protection and biocidal products and technical compliance of their fertilisers within the UK and EU. This wide-ranging role includes ongoing liaison with consultants, GLP laboratories and efficacy testing organisations alongside participation in various industry taskforces to ensure compliance with relevant UK and EU regulations. Location: This role is located … in Leicestershire Key Responsibilities: Manage the registration/renewal processes for the plant protection and biocidal products, coordinating with consultants and external GLP laboratories as well as overseeing product labelling and compliance. Conduct liaison with GLP laboratories to address data gaps and stay updated with changes to regulatory guidance. Support more »
teams • Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment Skills: GLP, GXP, Glassware, PPE, Stock, inventory management, inventory, distiller, descaling, laboratory, gmp Top Skills Details: GLP,GXP,Glassware,PPE,Stock,inventory management Additional Skills & Qualifications: Skills … role within a scientific environment. • Professional Certification/Associates degree in relevant field (Project Management, 6-Sigma, Business Administration, Supply Chain) • Basic understanding of GLP/GxP and/or experience working in a compliance driven environment. • Experience with 5S (Sort, Set in Order, Shine, Standardize, Sustain) principles • Sufficient knowledge more »
