8 of 8 GxP Jobs in the North West

that connect process development to manufacturing, enabling faster, more reliable tech transfer and batch release. Ensure architecture patterns comply with Life Sciences regulatory frameworks: GxP, 21 CFR Part 11, EU Annex 11, GAMP 5and data integrity requirements. Collaborate with client quality and regulatory affairs teams to embed compliance-by-design ...

JIRA, Confluence, LeanKit, ServiceNow, and asset management tools. Ability to quickly understand complex systems and business processes. Desirable Manufacturing, laboratory, or regulated environment experience. GxP and SDLC knowledge. Azure, AWS, or Power Platform experience/certifications. ...

throughout delivery and implementation phases. Nice to haves \n Experience with ClarOTy, Splunk, and ServiceNow. \n Manufacturing Operations experience. \n Regulated environments (SOX/GxP) experience. \n Pharma experience. ...

experience in the pharmaceutical/biotech industry, or other highly regulated industry. Proficiency in MS office and other software programs. Knowledge of cGMP/GXP standards Good attention to detail Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders. ...

role Certified auditor Minimum 10 years auditing experience. At least 30 audits in one or more of these areas: Computer System Validation (CSV), IT GxP compliance, AI GxP compliance, electronic data integrity. Minimum 15 years in Pharma/Med Device industry Fluent in English and ideally one other EU language … applications. Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem. Basic understanding of AI use cases and emerging GxP compliance requirements Experience in authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert ...

effective IT service desk and provide hands‐on technical support. Develop cybersecurity, data protection and information security frameworks. Support UK GDPR, ISO 27001, GxP and other relevant regulatory requirements. Lead business continuity, disaster recovery, patching and vulnerability management. Select and implement systems such as ERP, CRM, HR and collaboration platforms. … explain technical subjects clearly to non‐technical stakeholders. A practical, commercially aware and solutions‐focused approach. Experience with LIMS, ELN platforms, laboratory systems, GxP, MHRA guidance or FDA 21 CFR Part 11 would be particularly valuable. What’s next? If you are an experienced IT leader who enjoys combining strategy ...

templates, assessments, remediation plans and change controls for key or critical systems. - Review and approve key validation and project lifecycle documentation, including validation plans, GxP assessments, data migration plans, functional risk assessments, UAT/PQ test reports, validation reports, data migration reports and go/no-go decisions where appropriate. … quality, compliance, IT, systems or business-related discipline, or equivalent practical experience overseeing computerised systems in a regulated or compliance-led environment. - Experience in GxP, ERES, pharmaceutical, chemical, manufacturing, life sciences or another highly regulated environment. - Experience of Computer Systems Validation, system lifecycle documentation, change control and periodic review ...

responsibility, respecting CBL lab SOPs, sexed production planning and CBL lab production standards (details on following points below). - Ensure the CBL lab GxP on the flow cytometers operation and the sorting lab working area are observed and maintained. - Ensure the CBL Lab GxP on media preparation, processing of semen ...