2 of 2 Permanent GAMP Jobs in the South East

Bring Hands-on experience with Microsoft Intune, Entra ID, and Windows Server. Familiarity with ITIL processes and change management. Strong documentation and organisational skills. Awareness of regulatory frameworks (e.g., GAMP 5, FDA 21 CFR Part 11) is a plus. ? Why Join? Be part of a purpose-driven biotech company making a global difference. Work in a collaborative, fast-paced environment. 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 ❯