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 »
systems used for research, clinical trials, and data management. Key Responsibilities Quality Management: Implement and maintain IT quality control processes to ensure compliance with GxP, 21 CFR Part 11, and other regulatory requirements in IT systems. Data Quality Oversight: Regularly audit data quality for scientific and clinical trial data, identifying … data quality, or regulatory compliance, preferably within life sciences, pharmaceutical, or biotech industries. Technical Skills: Proficiency in data management and quality tools, knowledge of GxP, Part 11 compliance, CSV according to GAMP principles, experience of ISO27001 and SOC frameworks would be an advantage. Experience with IT systems such as AWS more »
a liaison between operations, QC, IT, third-party vendors, and Engineering to troubleshoot and resolve issues. Ensure that OT systems are maintained according to GxP, GMP, and cybersecurity standards, particularly ISA-95 security principles. Stay ahead of the OT technology roadmap by planning upgrades for legacy systems and ensuring that … and software, ensuring stability, security, and availability across systems. Provide hands-on operational support for OT environments, including setup, configuration, and troubleshooting. Contribute to GxP-compliant system documentation, test plans, and user acceptance testing. Essential Skills and Competencies Operational Experience: 5+ years of experience in IT design, build, and operational … 3+ years in a similar role, supporting systems in a laboratory or manufacturing environment, ideally in the healthcare or pharmaceutical industry. Strong understanding of GxP and GMP compliance in a highly regulated environment. Hands-on experience with IT infrastructure, networking, Active Directory (AD), and Windows operating systems. Technical Knowledge: Knowledge more »
client offers a generous package including a competitive salary, car allowance and bonus. You must have worked within the pharmaceutical industry with experience in GxP related CSV audits and inspections Role The main task is to manage and perform audits with focus on Computer System Validation (CSV) audits. Additional tasks … Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance Experience as a Lead Auditor on internal audits and external vendor audits. Experienced in GxP related CSV audits and inspections Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development Understanding of more »
client offers a generous package including a competitive salary, car allowance and bonus. You must have worked within the pharmaceutical industry with experience in GxP related CSV audits and inspections Role The main task is to manage and perform audits with focus on Computer System Validation (CSV) audits. Additional tasks … Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance Experience as a Lead Auditor on internal audits and external vendor audits. Experienced in GxP related CSV audits and inspections Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development Understanding of more »
Responsibilities Oversight and Compliance : IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls. Documentation and Review : Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/… process. Flexibility and adaptability in a changing regulatory environment. Education, Experience & Skills Required · Direct experience in leading, managing or participating in CSV projects in GxP environments. · B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years). · Extensive experience in … regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements. · GLP/GCP/GMP experience is preferable. · Experience in supporting regulatory inspections. more »
Bath, Bath and North East Somerset, Somerset, United Kingdom
VRS-UK
or understanding of the scientific industry essential. Candidate requirements: Degree in a Scientific discipline Industry experience working in a regulated laboratory environment (GLP, GMP, GxP) Knowledge of HPLC, GC or other chromatography techniques Experience working with LIMS systems Problem solving skills with effective solution evaluation Excellent communication skills UK driving … today for further information! Keywords: Software test, manual testing, automation, bug testing, HPLC, Liquid chromatography, LC, GC, Imaging, Clinical, Nuclear Medicine, Quality, GMP, GLP, GxP, ISO 9001, Bath, Bristol, Reading, South West, VRS8896MF Follow VRS Recruitment on LinkedIn to view all our latest vacancies! Please note that by submitting your more »
the IT System Administrator Ensure the Veeva and other relevant systems are maintained to the necessary regulatory and Dechra governance requirements and adhere to GxP Quality processes Participation in any Change Advisory Board meeting or other stakeholder groups, as appropriate Supporting the following processes for the Veeva System and Vaults … employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are: Experience with GxP, GAMP and/or of working with Veeva Systems and Vaults A background within the pharmaceutical sector would be ideal but not essential Data analysis more »
