The Successful Candidate - Strong experience with Microsoft Intune, Entra ID, Windows Server, and Microsoft 365- Familiarity with ITIL processes and SOP documentation- Understanding of compliance frameworks such as SOX, GAMP 5, or FDA 21 CFR Part 11- Excellent communication and problem-solving skills- Comfortable working in a fully office-based role What's on offer? - Competitive salary and benefits package More ❯
utilities, reactors, Pressure Filter Dryer, Centrifuge and Conical Dryer Also need to do the CSV on the vendor systems Needs to work closely with Automation and CQV teams. General GAMP V-Model project experience in efficient and compliant delivery of GXP Process Control Systems. Requirements: Degree (or Equivalent) in Analytical Chemistry, Chemistry, Biochemistry, Engineering or related field - or Significant relevant More ❯
Cramlington, Northumberland, North East, United Kingdom
MTrec Technical
to enable the development of project plans with key milestones. Ensure that all machinery supplied or modified is safe and in accordance with EC and UK regulations, harmonised standards, GAMP guidance and client standards. Develop the software and control systems for machines during commissioning in a structured and controlled way. Ensure all software and design drawings are up to date More ❯
Broadway, Worcestershire, United Kingdom Hybrid / WFH Options
Anglian Water Group Ltd
Test Strategies and related artefacts such as Policies and Procedures and managing test activities Knowledge and understanding of the software Lifecycle. Application of the V model as exemplified in GAMP 5 Experience of developing and using automated tools for configuration management and software testing, ideally some experience of SharePoint technologies and data manipulation (preferably JSON and XML) Experience of the More ❯
Specialist will support the Quality Assurance department in maintaining compliance of computerised systems and electronic Quality Management Systems (eQMS). This includes contributing to validation activities in alignment with GAMP 5, Annex 11, and other relevant regulations. The role requires an understanding of Computer System Validation (CSV) principles and practical involvement in regulated environments. Essential Functions To maintain and improve … requirements : None Education and Experience Bachelor's or Masters' degree in Life Sciences, Engineering, Computer Science, or related discipline desirable but not essential. Training in Computer System Validation or GAMP 5 preferred. Computer System Validation training desirable. Knowledge, Skills, and Abilities Proven experience working with ETQ, MasterControl, or similar eQMS platforms - configuration, administration, and user training. Strong working knowledge with … user access, and data integrity in Empower Demonstrable success in leading system migrations or large-scale QMS digitalisation projects. Experience in writing and maintaining validation documentation in line with GAMP 5. Good working knowledge of Computer System Validation. Familiar with electronic quality management systems (eQMS). Familiar with environmental monitoring systems. Experience working within a Quality function on computer systems More ❯