2 of 2 21 CFR Part 11 Jobs in England

including segregation and documentation, following established procedures. Communicate effectively with internal and external suppliers and stakeholders; act as the primary point of contact for part quality enquiries and escalate issues as necessary. Complete all assigned training within specified timeframes. Support other Quality functions at Sudbury, including in-process testing … Regulatory Compliance Represent the business during customer audits and regulatory inspections, demonstrating compliance with required systems. Maintain adherence to Data Integrity Regulations, GAMP standards, 21 CFR Part 11, and other relevant regulatory guidelines. Environmental, Health and Safety (EHS) Ensure compliance with safety, health, and environmental ...

Infrastructure and Networks. An understanding of IT Qualification activities would be beneficial. An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5. An understanding and appreciation of a Quality Management role ...