20 of 20 GxP Jobs

release; Technical operation and ongoing maintenance; Change management and system enhancements; Ensure compliance with internal IT standards, quality processes, and regulated industry requirements (e.g. GxP); Act as the primary system owner accountable for system performance, availability, and compliance; Maintain and continuously update system architecture documentation throughout the system lifecycle; Collaborate ...

Work closely with Warehouse, Quality, Manufacturing, Validation and IT teams Support SIT, UAT, defect resolution and process alignment Ensure EWM processes align with GMP, GxP, validation and audit requirements Produce and maintain functional specifications, test scripts and validation evidence Required Skills & Experience Proven experience as an SAP EWM Consultant Strong ...

offshore functional teams Requirements: Strong SAP PP/Manufacturing experience, ideally on S/4HANA Proven experience leading workstreams on transformation programmes Pharmaceuticals experience (GxP, batch, regulated environments) Track record in client-facing consulting roles (Big 4/SI preferred) Experience across design, build, and deployment phases Contract Details: Initial ...

years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory ...

need to succeed Experience within manufacturing, pharma, or highly regulated environments A background in automation, manufacturing systems, or site IT Knowledge of GMP/GxP environments and regulated systems Exposure to systems such as MES, LIMS, SCADA, PLC, or process control (advantageous) Strong stakeholder engagement skills, with the ability ...

this rewarding opportunity! Required Qualifications: Experience: experience as a Scrum Master, with a proven track record of successfully delivering software development projects. Pharma GxP software development experience preferred Agile Expertise: Strong knowledge of Agile methodologies (e.g., Scrum, Kanban) and best practices. Leadership and Communication: Excellent leadership, communication, and interpersonal skills ...

regulated environments Experience Required Proven experience in regulated industries (e.g. EHS, Quality, Compliance, Risk, Audit) Strong understanding of frameworks such as ISO standards, RIDDOR, GxP, or similar Demonstrated experience defining or owning standards, policies, or frameworks Experience making real-world regulatory or operational decisions (not purely advisory) Strong leadership experience ...

regulated environments Experience Required Proven experience in regulated industries (e.g. EHS, Quality, Compliance, Risk, Audit) Strong understanding of frameworks such as ISO standards, RIDDOR, GxP, or similar Demonstrated experience defining or owning standards, policies, or frameworks Experience making real-world regulatory or operational decisions (not purely advisory) Strong leadership experience ...

n. Key areas of expertise inclu de:LabWare LIMS configuration, development, and implementat ionLaboratory workflow analysis and process optimisat ionComputer System Validation (CSV) and GxP complia nceDocumentation lifecycle management and regulatory requireme ntsProject planning, delivery, and stakeholder managem entMolecular biology and microbiology laboratory environme ntsMedical device manufacturing and quality syst ...

analytics solutions for regulated industries (Life Sciences/Pharma). The ideal candidate will drive requirement gathering, compliance alignment, and stakeholder engagement for a GxP-compliant, cloud-native data platform on Microsoft Fabric and Azure. Success will be measured by the ability to translate CDM/Biostatistics needs into validated … Leads requirement gathering & documentation across CDM, Biostatistics, and vendor partners. Translates business and regulatory needs into functional specifications aligned with 21 CFR Part 11, GxP, and HIPAA. Supports validation frameworks, audit-ready documentation, and reporting requirements such as Power BI dashboards and compliance scorecards. Facilitates workshops, UAT sessions, and milestone ...

updates to programme leadership and steering committees. Lead third-party vendors, system integrators, and infrastructure partners throughout the project lifecycle. Ensure compliance with GMP, GxP, CSV and regulatory requirements. Required Experience Proven experience delive ring Körber PAS-X (Werum P AS-X) projects within pharmaceutical or life sciences environments. Previous … resource planning. Experience managing external vendors and system integrators. Preferred Experience Pharmaceutical, Biotechnology or Life Sciences manufacturing background. Experience within regulated GMP/GxP environments. Knowledge of Computer System Validation (CSV) requirements. Familiarity with cloud migration and infrastructure modernisation programmes. PMP, PRINCE2, Agile or equivalent project management certification. Key SkillsPAS ...

evolving organisation. Responsibilities Quality Management & Compliance Maintain and enhance the Quality Management System (QMS) in line with applicable standards (e.g. ISO 13485, ISO 9001, GxP as relevant) Ensure organisational compliance wi3th internal quality policies and external regulatory requirements Support quality strategy aligned with product and organisational growth Audit & Inspection Readiness … regulated environments (e.g. pharma, biotech, medtech, or digital health) Strong knowledge of: QMS frameworks (ISO 13485, ISO 9001, or similar) Regulatory and compliance principles (GxP, data integrity, audit readiness) Experience supporting audits and inspections Strong understanding of documentation, SOP development, and process control Excellent organisational skills with high attention ...

this rewarding opportunity! Position Overview: Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing areas. Responsibilities … years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting. Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications Experience in Data ...

Cardiovascular, Oncology, Endocrinology, and Neurology. About the Role We are looking for an experienced Computerised Systems Compliance Manager to help safeguard patient safety through GxP compliance and data integrity. Responsibilities Provide overall compliance oversight for all GxP computerised systems across Pharmanovia Ensure systems comply with regulatory expectations, including EU Annex … perspective Qualifications Essential Experience & Knowledge Demonstrated experience managing computerised systems validation in a pharmaceutical, biotech, or life sciences environment, with a strong focus on GxP compliance and validation processes. Must have 3-5 years of experience working with Trackwise Digital. Experience with leading EQMS & ERP systems with a strong background ...

across SAP QM processes Work closely with Quality, Manufacturing, Validation and IT stakeholders Support SIT, UAT and defect resolution activities Ensure solutions align with GxP, validation and audit requirements Produce and maintain functional documentation, test scripts and evidence Required Skills & Experience Proven experience as an SAP QM Consultant Strong hands … knowledge of SAP Quality Management Experience with Batch Release Management processes Background working in GxP-regulated or compliance-driven environments Strong understanding of design, build, test and deployment phases Excellent stakeholder management and documentation skills Ability to work independently within a project delivery environment Desirable Experience with SAP Batch Release ...

while collaborating closely with development, QA/UAT, and project management teams to ensure successful delivery Experience/Knowledge of Clinical operations processes and GxP/regulatory environments Must understand GXP system validation process and familiar with AWS environments Experience gathering and documenting business requirements and process flows Experience … able to independently handled all BA experience Partners with the Validation team to ensure testability of requirements and release readiness AWS, UAT, GxP, clinical industry, BRDs ...

eQMS processes and QA Induction for staff at the site (Change Controls, Deviations & Quality Events) Supplier Performance reviews computer systems Performing internal audits across GxP areas Perform QA review of DQA procedures/work instructions. Management of sites QA Training Matrix. Maintenance of Adobe Risk Register and user list. Signix … desirable. Quality experience in a pharmaceutical environment A degree (or equivalent) in a scientific discipline (desirable). Clear understanding of GMP or any other GxP area, regulatory and accreditation systems, and quality management. Excellent analytical thinking to evaluate information and understand complicated issues. Excellent interpersonal skills to be able ...

environment, supporting mission‐critical applications that enable research, clinical processes. The role has a direct impact on compliance with global regulatory standards (e.g., GxP/CSV), ensuring system reliability, and uninterrupted delivery of ongoing innovation initiatives. You will work on complex, integrated platforms leveraging modern engineering practices and tools (e.g. … system integrations, ensuring timely issue resolution. Drive end-to-end compliance activities including validation documentation, audit readiness, and adherence to regulatory standards (CSV/GxP). Oversee multiple concurrent workstreams with competing priorities in resource-constrained environments, ensuring optimal delivery outcomes. Proactively manage risks, issues, and schedule pressures, implementing mitigation ...

Principal Cloud Architect | Hybrid | £80,000-£100,000 About the Role: We're partnering with a growing SaaS business to hire a Principal Platform Architect to own the design, security, reliability, and operational management of ...

Platform Architect | Hybrid | £70,000-£100,000 About the Role: We're partnering with a growing SaaS business to hire a senior Platform Architect to own the design, security, reliability, and operational management of their ...