gamp iq jobs
1-4 of 4 jobs "gamp"
will have a strong Instrument and process Controls Background, 2-3 years GMP / GAMP experience... and review project specification and validation documents in line with the GAMP project life cycle Change... control and configuration in compliance with site and regulatory standards including GAMP 4... and 21CFRPart11. Preparation and reviewing of URS,FDS,IQ,OQ,PQ and other Computer Systems Validation Documentation
Experience: 2
Pharma Manufacturing Start-Up experience; Solid understanding of Pharma (FDA, EU) regulations and Guidelines (GAMP, ISPE Baseline Guides etc) with respect to automation and computer systems; Preparation of: Validation Plans... , Requirements, Specifications, Design, Risk Analysis, IQ/OQ/PQ Test Documentation, Reports, SOPs, WIs; Managing validation testing activities; Working with validation change control and configuration management; Engineer level S88
Contract: Contract
will have a strong Instrument and process Controls Background, 2-3 years GMP / GAMP experience... and review project specification and validation documents in line with the GAMP project life cycle Change... control and configuration in compliance with site and regulatory standards including GAMP 4... and 21CFRPart11. Preparation and reviewing of URS,FDS,IQ,OQ,PQ and other Computer Systems Validation Documentation
Experience: 2
will have a strong Instrument and process Controls Background, 2-3 years GMP / GAMP experience... and review project specification and validation documents in line with the GAMP project life cycle Change... control and configuration in compliance with site and regulatory standards including GAMP 4... and 21CFRPart11. Preparation and reviewing of URS,FDS,IQ,OQ,PQ and other Computer Systems Validation Documentation
Experience: 2