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Opis:

Validation Consultant Nr ref.: /JOBS.pl Our client, is a consultantcy company working directly for the pharmaceutical market. They now have a requiement for a QA & Validation consultant to work with one of their top global pharmaceutical clients. Summary • The successful candidate will become a Quality Assurance Validation Consultant in their life sciences compliance consulting business. • The contract term is 6 months. Subsequent contracts are dependent on business conditions and candidate performance. • You will join a small team that is focussed on Computerised System/IS compliance for a global top 20 pharma client • The successful candidate will be educated to a minimum of B.Sc. level, and will have a minimum of three years working in a regulated pharmaceutical GxP environment in some or all of the following areas: quality assurance, computer system validation, information technology. • The success of our business depends on continually exceeding client expectations, and it is against this standard that candidates will be measured. Responsibilities • Provide consultancy and support in the assurance of regulatory compliance for computer systems, computer system validation and IT processes. • Schedule and carry out periodic reviews of computerised systems • Support the data integrity program for the site. • Development and review of validation documentation and procedures. • Provide consultancy and support for QC/QA IS related business as usual computer system activities and projects. • Participation in the change management process for computerised systems • Track and manage to closure: Quality System Deviations, risks, issues, and audit observations. • Support QA with the development of effective relationships with GMP process owners, GMP computer system owners, service providers. • Partake in and provide support to the client during customer audits and regulatory inspections; • To collect new developments in external GMP requirements for computer system validation and IT compliance and to train relevant personnel as appropriate. • Actively participate in operational excellence initiatives. • As/if a need arises, participate in audits of service providers and other third parties to assess compliance with pharmaceutical regulations and client policies and standards. • As/if a need arises, perform formal, structured assessments of computerised systems against client policies and standards. Experience • Minimum 3-5 years pharmaceutical industry experience, in an IMB and/or FDA regulated (GxP) environment. • Knowledge and experience of GAMP 5 or equivalent models. • Knowledge and experience of data integrity requirements. • Experience of working in an outsourced IT services environment. Summary • The successful candidate will become a Quality Assurance Validation Consultant in their life sciences compliance consulting business. • The contract term is 6 months. Subsequent contracts are dependent on business conditions and candidate performance. • You will join a small team that is focussed on Computerised System/IS compliance for a global top 20 pharma client • The successful candidate will be educated to a minimum of B.Sc. level, and will have a minimum of three years working in a regulated pharmaceutical GxP environment in some or all of the following areas: quality assurance, computer system validation, information technology. • The success of our business depends on continually exceeding client expectations, and it is against this standard that candidates will be measured. Responsibilities • Provide consultancy and support in the assurance of regulatory compliance for computer systems, computer system validation and IT processes. • Schedule and carry out periodic reviews of computerised systems • Support the data integrity program for the site. • Development and review of validation documentation and procedures. • Provide consultancy and support for QC/QA IS related business as usual computer system activities and projects. • Participation in the change management process for computerised systems • Track and manage to closure: Quality System Deviations, risks, issues, and audit observations. • Support QA with the development of effective relationships with GMP process owners, GMP computer system owners, service providers. • Partake in and provide support to the client during customer audits and regulatory inspections; • To collect new developments in external GMP requirements for computer system validation and IT compliance and to train relevant personnel as appropriate. • Actively participate in operational excellence initiatives. • As/if a need arises, participate in audits of service providers and other third parties to assess compliance with pharmaceutical regulations and client policies and standards. • As/if a need arises, perform formal, structured assessments of computerised systems against client policies and standards. Experience • Minimum 3-5 years pharmaceutical industry experience, in an IMB and/or FDA regulated (GxP) environment. • Knowledge and experience of GAMP 5 or equivalent models. • Knowledge and experience of data integrity requirements. • Experience of working in an outsourced IT services environment. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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