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 ❯
for data generation as needed. What you'll need to succeed Extensive management of testing across the Test Delivery Lifecycle and within regulatory domains (GXP, SoX). Proven experience managing multiple concurrent projects using Agile, Waterfall, and hybrid methodologies. Proficiency with Performance Test tools (e.g., LoadRunner, NeoLoad) and Test Management More ❯
and other Abbott departments. Awareness of how enterprise software is managed and maintained will be beneficial, as will an interest in the system lifecycle, GxP, and CSV (Computer Systems Validation). Continuous Improvement is an important part of our site's culture and as such, you will be heavily involved 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 ❯
enterprise architect in the Pharma or other highly regulated industry. At least 3 years experience operating under regulations that impact the Pharma industry (e.g. GxP, GDPR, Sarbanes Oxley) at global level. No less than 5 years experience on Adobe stack (AEM, Adobe Analytics, Adobe Target). 3 years of experience More ❯
ability to communicate between technical and non-technical teams? Familiarity with Agile and/or Prince2 methodologies? Excellent communication and interpersonal skills? Awareness of GxP regulations? SAP knowledge (e.g. S/4HANA) is nice to have. If you are interested, please do apply :) All of our opportunities require that applicants More ❯
Cambridge, Cambridgeshire, United Kingdom Hybrid / WFH Options
Moonlake
Maintain and develop QMS tracking tools. Work with other members of the MoonLake Quality Team, ensuring the timely and logical location and storage of GxP documentation. As part of the Quality Team, ensure actions are communicated to client groups and progress tracked. As part of the Development Quality team, develop 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 ❯
Stevenage, Hertfordshire, United Kingdom Hybrid / WFH Options
ENGINEERINGUK
changes to programming best practices. Apply standard processes to tasks, ensuring that deliverables are accurate, high quality and met according to agreed timelines Understand GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable) Quickly understand and implement internal processes and standards in assigned work Perform More ❯
successful in this role, you should demonstrate: Strong experience of Computer System Validation in the pharmaceutical industry. A solid understanding of validation principles and GxP regulations. Prior experience with ERP systems, including some involvement in their validation. Strong IT skills and proficiency in standard office software (e.g., Microsoft Word, Excel More ❯
successful in this role, you should demonstrate: Strong experience of Computer System Validation in the pharmaceutical industry. A solid understanding of validation principles and GxP regulations. Prior experience with ERP systems, including some involvement in their validation. Strong IT skills and proficiency in standard office software (e.g., Microsoft Word, Excel More ❯
within validated parameters. Create and maintain validation documentation, including protocols, test scripts, and validation reports. Ensure that all automation systems comply with industry standards, GxP guidelines, and regulatory mandates. Maintain accurate and organized documentation for all validation activities, including equipment and software specifications, validation protocols, and records. Collaborate with our 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 ❯
will build competency/capability in the effective use of the solution and demonstrate compliance with relevant legal and/or regulatory requirements, e.g. GxP, health authority requirements. Collaborates closely with other experts across Reg Tech or more widely (e.g. OSSE, IT, external partners) who are involved in the design More ❯
in cross-module functionalities to drive end-to-end business process efficiency. Ability to design, configure, and troubleshoot SAP FICO processes in a validated (GxP-compliant) environment. Experience in release management, ensuring high-quality system enhancements and changes. Drive system documentation excellence in compliance with GxP and other regulatory requirements. More ❯
problem areas Evidence of experience of the management of change Active management of plant changes in a controlled and safe way Understanding of what GxP and ALCOA are Monitoring and reviewing engineering progress with Project Services and Engineering disciplines Ability to be a focal point for assigned projects, managing issues More ❯
is seeking a QA Compliance Manager for a 12 month Fixed Term Contract. This role will lead and ensure that IT systems critical to GxP operations comply with regulations. You will be part of a supportive team focused on maintaining high standards in quality management and data integrity. Please note … that to be considered for this role you must have the right to work in this location. Responsibilities: Ensure IT systems meet GxP compliance standards. Support adherence to manufacturing and data integrity regulations. Oversee system validation and compliance processes. Review and manage changes to IT systems. Provide guidance on data … and Requirements: Previous experience within pharmaceuticals or biotechnology companies Must have previous experience in data integrity and system validation. Knowledge of IT compliance and GxP systems. Strong communication and stakeholder management skills. Proficient in using Word and Excel for data analysis. Detail-oriented with excellent report writing skills. Ability to More ❯
is seeking a QA Compliance Manager for a 12 month Fixed Term Contract. This role will lead and ensure that IT systems critical to GxP operations comply with regulations. You will be part of a supportive team focused on maintaining high standards in quality management and data integrity. Please note … that to be considered for this role you must have the right to work in this location. Responsibilities: Ensure IT systems meet GxP compliance standards. Support adherence to manufacturing and data integrity regulations. Oversee system validation and compliance processes. Review and manage changes to IT systems. Provide guidance on data … and Requirements: Previous experience within pharmaceuticals or biotechnology companies Must have previous experience in data integrity and system validation. Knowledge of IT compliance and GxP systems. Strong communication and stakeholder management skills. Proficient in using Word and Excel for data analysis. Detail-oriented with excellent report writing skills. Ability to More ❯
overseeing and assisting in the successful implementation of all digital lab system equipment for Quality laboratory operations, ensuring all digital equipment and systems meet GxP standards. This role will also involve the integration and implementation of systems such as LIMs, LES, Clinical Data Management Systems (CDMS) and Scientific Data Management … functions are optimized and compliant with relevant regulatory requirements. Duties: Lead implementation of digital quality lab systems across all lab functions, ensuring compliance with GxP standards for digital equipment. Collaborate with cross-functional teams to ensure integration and transition of processes, including the integration of systems such as LIMs, LES … CDMS, and SDMS. Implement and ensure the compliance of all digital lab equipment with GxP requirements, including calibration, validation, and data integrity. Conduct system configuration and customization. Ensure that all digital equipment, LIMS, LES, CDMS, and STMS meet regulatory standards (e.g., GMP, ISO, 21 CFR Part 11, GxP) during the More ❯
and processes to support the organisation in achieving multiple industry accreditations within defined industry standards (e.g., ISO 27001/27101, NIST, Cyber Essentials, GDPR, GXP, etc.). Key Responsibilities: Build, mentor, and lead a high-performing, professional cybersecurity team. Develop and execute a comprehensive cybersecurity roadmap aligned with EIT's … SIEM, EDR/XDR, Firewalls, IDS/IPS, DLP, and IAM solutions. Working knowledge of security frameworks: ISO 27001, NIST, CIS, SOC 2, GDPR, GXP, etc. Experience in cloud security. Proficient in threat modeling, penetration testing, vulnerability management, and security incident response. Demonstrated ability to build security teams and drive More ❯
extended its flexible, scalable solutions to the IDBS Polar and PIMS cloud platforms to help scientists make smarter decisions with assured confidence in both GxP and non-GxP environments. Do you want to work in a dynamic, fast paced, high performing, safe to fail and fun environment which is founded More ❯
overseeing and assisting in the successful implementation of all digital lab system equipment for Quality laboratory operations, ensuring all digital equipment and systems meet GxP standards. This role will also involve the integration and implementation of systems such as LIMs, LES, Clinical Data Management Systems (CDMS) and Scientific Data Management … functions are optimized and compliant with relevant regulatory requirements. Duties: Lead implementation, of digital quality lab systems across all lab functions, ensuring compliance with GxP standards for digital equipment. Collaborate with cross-functional teams to ensure integration and transition of processes, including the integration of systems such as LIMs, LES … CDMS and SDMS. Implement and ensure the compliance of all digital lab equipment with GxP requirements, including calibration, validation, and data integrity. Conduct system configuration and customization Ensure that all digital equipment, LIMS, LES, CDMS, and STMS meet regulatory standards (e.g., GMP, ISO, 21 CFR Part 11, GxP) during the More ❯
equipment-related issues. Configure and manage data flows for specialized scientific instruments to support research activities. Implement and maintain data backup solutions for both GxP and non-GxP laboratory environments. Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Proven expertise in … integrate AI solutions into operational practices. Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Experience with validated systems (GxP) preferred. Experienced in Agile methodologies, emphasizing iterative development and collaboration. Familiarity with ServiceNow or similar ticketing systems, supporting incident and request management workflows. Experience leading More ❯
equipment-related issues. Configure and manage data flows for specialized scientific instruments to support research activities. Implement and maintain data backup solutions for both GxP and non-GxP laboratory environments. Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Proven expertise in troubleshooting complex … integrate AI solutions into operational practices. Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Experience with validated systems (GxP) preferred. Experienced in Agile methodologies, emphasizing iterative development and collaboration. Familiarity with ServiceNow or similar ticketing systems, supporting incident and request management workflows. Experience leading More ❯