is expected, along with the responsibility for documenting and refining IT processes to increase operational efficiency and effectiveness. (20%) Compile technology-related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation together with relevant IT QMS documentation. (20%) Manage or more »
development and debugging, and executing complex programming activities skills Experience using standard macro development process Experience in CDISC standards and its application Good Practice (GxP), and International Council for Harmonization (ICH) requirements experience Experience with Microsoft Office software (MS Word, Excel, PowerPoint, Outlook) Experience with submission activities and related documentation more »
executing complex programming activities skills. Knowledge of standard macro development process. Strong expertise in CDISC standards and its application. Strong knowledge of Good Practice (GxP), and International Council for Harmonization (ICH) requirements. Knowledge of Microsoft Office software (MS Word, Excel, PowerPoint, Outlook). Expertise with submission activities and related documentation. more »
resolving general networking issues. Experience: Extensive IT/Commercial experience gained within a fast-paced environment? Experience of GAMP 5 and working within a GxP environment in providing superior customer service and support. Experience of working within a technical support position, covering Windows, Microsoft Office, Internet Explorer and various business more »
adhered to with handling, processing, security & privacy of data, compliant with internal security, risk management policies and practices, external regulatory and statutory requirements e.g., GxP, Sarbanes Oxley and that Tech continuity plans are in place for all business-critical products. Build relationships both internally & externally, collaborating closely with technologists and more »
Novartis global Information Security and Quality standards and policies for all products/services. Ensuring regulatory compliance (e.g., GLP & GCP) standards and policies for GxP products/services, if applicable. Ensuring operational activities and outcomes are reflected on product roadmaps. Engaging with other product teams within and across product lines more »
adhered to with handling, processing, security & privacy of data, compliant with internal security, risk management policies and practices, external regulatory and statutory requirements e.g., GxP, Sarbanes Oxley and that Tech continuity plans are in place for all business-critical products. Build relationships both internally & externally, collaborating closely with technologists and more »
adhered to with handling, processing, security & privacy of data, compliant with internal security, risk management policies and practices, external regulatory and statutory requirements e.g., GxP, Sarbanes Oxley and that Tech continuity plans are in place for all business-critical products. Build relationships both internally & externally, collaborating closely with technologists and more »
of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture Core Competencies (Technical): 3+ years GxP (life science, pharma, med device) experience Experience with automation system implementation and validation Working knowledge of DCS Systems (800xA & Advant) PI/RtReports would be more »
hardware, software and users. Understanding and adhering to the relevant aspects of Company and the Lab procedures (e.g. SOX Controls, Health and Safety policy, GxP, ISO27001). Working with Lab managers across the departments on site. In depth knowledge of Anti-Virus administration for IT Lab hardware and software. General more »
AZ IT Policies and Standards. Essential Skills/Experience Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes Oxley Extensive experience in multiple areas of quality and compliance within a Pharmaceutical/Biotech environment Leading diverse groups of quality, compliance more »
Cambridge, Cambridgeshire, UK Hybrid / WFH Options
SKG Consulting
development software alternatives, and/or integrate purchased solutions. Understands and adheres to corporate standards regarding applicable company policies, including code of conduct, safety, GxP compliance, data security, and the software development lifecycle. Delivers new and ongoing projects on time. Manages time allocations and work priorities across teams and projects. more »
Excellent leadership, problem-solving, and communication skills. Excellent written and verbal communication skills in English. Desirable Skills/Experience Strong understanding and experience with GxP systems and compliance is advantageous but not essential. Ready to make a difference? Apply now to join our team! #J-18808-Ljbffr more »
Confluence with some experience of Jira configuration. An understanding of DevOps and the associated benefits, along with an understanding of clinical trials, GCP, and GxP would also be advantageous. In addition, experience of hands-on software testing and requirements analysis would be helpful. #J-18808-Ljbffr more »
hardware, software and users. Understanding and adhering to the relevant aspects of Company and the Lab procedures (e.g. SOX Controls, Health and Safety policy, GxP, ISO27001). Working with Lab managers across the departments on site. In depth knowledge of Anti-Virus administration for IT Lab hardware and software. General more »
microservice architectures e.g., Kubernetes, Docker and serverless approaches. Experience with Continuous Integration and building continuous delivery pipelines, such as CodePipeline, CodeBuild, and Code Deploy. GxP experience. Excellent communication, analytical and problem-solving skills. Desirable Skills/Experience Experience building large scale data processing pipelines. e.g., Hadoop/Spark and SQL. more »
partnering with other Gilead information technology groups to enhance and improve R&D systems and related technical infrastructure. Good Practice quality guidelines and regulations (GxP) systems validation and user acceptance testing is also a specific responsibility of R&D Information Systems. R&D Information Systems may also provide technical support more »
design, build, and operational support OR 3+ years in a similar role with Manufacturing OT equipment, in Healthcare/Pharma. 3+ years working with GxP and GMP environments. If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lauren.mckinley@skillsalliance.com. more »
Stevenage, Hertfordshire, United Kingdom Hybrid / WFH Options
GlaxoSmithKline
Risk & Compliance: Support operational technology compliance with internal security and risk management policies and practices, as well as external regulatory and statutory requirements e.g. GxP and that Tech continuity plans are in place for all critical areas. People Management: Collaborate with internal owners of security technologies such as antivirus, IDS more »
protocol execution. Manage and approve vendor’s documentation as appropriate. Ability to impact and influence people/areas in matters related to Validation and GxP compliance. Ability to work in a fast-moving dynamic small company environment. Ability to mentor junior team members. Experience in other validation areas which may more »
between insourced vs. outsourced models for IT services. Enterprise Architecture Own technology standards assessment and adoption for IT technologies. Manage the systemic integration of GxP compliant IT systems within the company's research, manufacturing, and clinical activities. Develop, implement, and maintain IT policies, procedures, and associated plans for security, data … a degree, or concentration in, Computer Science, Information Technology, or related discipline. Experience in a pharmaceutical or biotechnology or related environment, and specifically with GxP systems. Knowledge of both PC and Mac-based hardware and software and their coexistence and integration. Experience working with Commercial organization supporting an external sales more »
between insourced vs. outsourced models for IT services. Enterprise Architecture Own technology standards assessment and adoption for IT technologies. Manage the systemic integration of GxP compliant IT systems within the company's research, manufacturing, and clinical activities. Develop, implement, and maintain IT policies, procedures, and associated plans for security, data … a degree, or concentration in, Computer Science, Information Technology, or related discipline. Experience in a pharmaceutical or biotechnology or related environment, and specifically with GxP systems. Knowledge of both PC and Mac-based hardware and software and their coexistence and integration. Experience working with Commercial organization supporting an external sales more »
between insourced vs. outsourced models for IT services. Enterprise Architecture Own technology standards assessment and adoption for IT technologies. Manage the systemic integration of GxP compliant IT systems within the company’s research, manufacturing, and clinical activities. Develop, implement, and maintain IT policies, procedures, and associated plans for security, data … a degree, or concentration in, Computer Science, Information Technology, or related discipline. Experience in a pharmaceutical or biotechnology or related environment, and specifically with GxP systems. Knowledge of both PC and Mac-based hardware and software and their coexistence and integration. Experience working with Commercial organization supporting an external sales more »
We are looking for a Software Tester to join our growing team, working on Laboratory Information Management Systems (LIMS) . This is a fantastic opportunity for someone with some experience in software testing who is looking to develop their skills more »
Software Tester - LIMS Remote - Work From Home We are looking for a Software Tester to join our growing team, working on Laboratory Information Management Systems (LIMS) . This is a fantastic opportunity for someone with some experience in software testing more »
