17 of 17 Remote/Hybrid GMP Jobs

ownership of ERP and other computerized system validations (IQ, OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs). Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines. ERP & System Expertise: Work hands-on with ERPs, eDMS, eQMS, LIMS, laboratory ...

Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processesKnowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11Proven ability to work both independently and in teams in a dynamic, fast-moving environmentGood understanding of SaaS and GxP principlesAbility to quickly understand business ...

experience leading IT at a senior management level Track record of delivering results quickly Experience in delivering IT services to customers Work in a GMP or highly regulated environment Preferred Experience: Experience of agile product development Experience of Lean Six Sigma Infrastructure delivery (networking, hardware) to customers Experience with data ...

experience leading IT at a senior management level Track record of delivering results quickly Experience in delivering IT services to customers Work in a GMP or highly regulated environment Preferred Experience: Experience of agile product development Experience of Lean Six Sigma Infrastructure delivery (networking, hardware) to customers Experience with data ...

contact the recruiter directly. Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo ...

beneficial.Experience working with health authorities and supporting regulatory discussions and responses, underpinned by a solid understanding of global development and post-approval requirements, GMP expectations and regulatory practices in at least one ICH region.Able to analyse technical data, create clear regulatory narratives, identify gaps early and manage traceable content across ...

experience in programmatic advertising, with a deep knowledge of the Google Stack, Google Ads (Display/Video), DSP (e.g. Adform, Tradedesk, DV360, Amazon DSP), GMP and Analytics Strong understanding of the digital advertising ecosystem, including DSPs, DMPs, and ad exchanges Strong analytical skills and ability to provide insights and recommendations ...

experience in programmatic advertising, with a deep knowledge of the Google Stack, Google Ads (Display/Video), DSP (e.g. Adform, Tradedesk, DV360, Amazon DSP), GMP and Analytics Strong understanding of the digital advertising ecosystem, including DSPs, DMPs, and ad exchanges Strong analytical skills and ability to provide insights and recommendations ...

implement, and support MES in its production facilities. You will bridge manufacturing and digital systems, focusing on data integrity, efficiency, and regulatory compliance across GMP environments. The role requires 3+ years configuring MES platforms, exposure to SAP integration, and strong SQL skills. Hybrid work in Hook/Speke, UK, with ...

audit trails, electronic signatures, role-based access, segregation of duties, data integrity, master data, time synchronisation and lifecycle controls . Ensure architectural decisions support GMP, GxP, data integrity, patient safety, product quality and inspection readiness . Partner with Engineering, Automation, Manufacturing, Quality, Validation, Cybersecurity, Infrastructure, Data, Applications and senior site … experience designing OT/IT architectures within pharmaceutical, life sciences, chemical, food & beverage or similarly regulated manufacturing environments . Strong understanding of GxP/GMP regulated environments and the implications these have on technology architecture. Experience with IT/OT convergence and industrial control environments . Strong understanding ...

must be eligible Job Purpose The Salesforce Application & Analytics Manager will be responsible for the strategic management, support, development, and continuous improvement of the GMP Application and associated analytics capabilities. The role will ensure the effective operation of the Salesforce platform, delivery of the application roadmap, and development of high … driving innovation and data-driven decision-making. Key Responsibilities Salesforce Application Management Own the day-to-day administration, maintenance, support, and enhancement of the GMP Application hosted on the Salesforce platform. Act as the primary subject matter expert for the application, ensuring stability, performance, and user satisfaction. Develop and maintain ...

space - clinical trial systems, clinical data quality, and inspection readiness for sponsors and CROs - though the team also picks up broader GxP work (GMP, GDP, GLP‐adjacent systems) where a client needs it. Most clients sit in the 30-200 employee range - organisations sophisticated enough to know exactly what they … client‐facing consultancy role as opposed to purely in‐house Inspection experience with FDA, MHRA, or EMA specifically involving GCP systems Broader GxP exposure - GMP, GDP, or quality systems outside clinical trials - for consultants who want to flex across service lines Familiarity with eQMS implementation, data migration validation ...

Specialist to deliver data services to our clients, which include data and benefit audits, preparing data strategies and plans, undertaking various pension rectifications including GMP rectification and equalisation. While we continue to help clients meet their GMP objectives, the data challenges our clients face are becoming more diverse which gives ...

Onyx-Conseil in Stevenage offers a hybrid IT Director role to shape the IT strategy and governance for a GMP-regulated environment. The position leads external and internal customers, directs a 15-person IT team, and partners with senior leaders to enable clinical, regulatory and manufacturing workflows. You will drive ...

critical process equipment, with three days on site per week, and the rest remote. You will drive design assurance, stakeholder engagement, and compliance with GMP and SHE requirements across all design stages. #J-18808-Ljbffr ...

contractor pre-qualification, technical assessment and selection. Produce regular Design Assurance Reports to ensure ongoing technical alignment. Identify and support value engineering opportunities. Ensure GMP and SHE requirements are appropriately reflected within design deliverables. Participate in SHE and technical risk assessment activities and ensure appropriate mitigations are incorporated into … manufacturing environment. Strong experience across controls and instrumentation engineering within major capital projects. Experience providing technical leadership, design assurance and governance. Strong understanding of GMP and engineering requirements within a pharmaceutical environment. Experience working with Design Contractors, suppliers and Work Package Owner teams. Experience reviewing technical specifications, drawings, calculations ...