4 of 4 21 CFR Part 11 Jobs in the UK excluding London

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 … 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 more »

HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching … drawings, and Standard Operational Procedures (SOP), including Administrative SOPs and Job Plans. Conversant with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, User Security, System Disaster Recovery, Data Backup & Restore). As Automation System Owner, lead new product more »

We are looking to recruit an experienced Computer Systems Validation Engineer who has a good knowledge of Gamp 5 guidelines, 21 CFR and Anex 11 regualtory standards. You will ideally have gained experience as a CSV Engineer in either the Bio Technology or Pharaceutical sectors. You should more »

Midlands. Salary and benefits are excellent, and will reflect your qualifications and contribution. The role The role requires a driven individual to work as part of a multi-disciplinary team creating bespoke automation solutions to solve our clients manufacturing and testing needs. The role includes PLC/HMI design … Robot programming, Vision systems, and any other technology that is required to meet our customers' requirements. Responsibilities Discussion with clients and internal staff as part of a multi discipline team to respond to requirements and design a concept. Aid with the development of cost estimates as part of … mechanical and pneumatics principles Beckhoff/Siemens control systems experience Experience working in the pharmaceutical industry Familiarity with GAMP/21CFR11/Eu Annex 11/GMP Experience with developing Robots, Machine vision, SCADA/MES Experience working with communication protocols e.g. EtherCAT, Profinet, CAN, IP, Serial etc. Experience more »