4 of 4 GAMP Jobs

Learn4U efficiently. 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 (SHE) legislation. Promote ...

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 within an IT Organisation, in particular the Software Development Life Cycle (SDLC), including System Planning, Specification ...

standard software blocks Supporting FATs, installation, testing and commissioning on site Troubleshooting and resolving control system issues Ensuring compliance with industry standards including ATEX, GAMP, FDA and SIL Where you'll be doing it You'll be joining a specialist engineering business delivering automated pharmaceutical manufacturing equipment. The team works ...

activities for laboratory systems and instruments Produce and review validation documentation including URS, validation plans, IQ, OQ, PQ and reports Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity standards Support risk assessments, system changes and new system implementations Work closely with … validation within a GxP laboratory environment Experience working with lab systems such as LIMS, ELN or CDS platforms Strong knowledge of regulatory standards including GAMP 5 and 21 CFR Part 11 Experience producing validation documentation and executing test protocols This is a contract opportunity to join a high profile programme ...