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QA Validation Consultant (Swedish Speaker)
Eingestellt von Silverlink Technologies
Gesuchte Skills: Consultant
Projektbeschreibung
ROLE- QA VALIDATION CONSULTANT
Location- Södertälje, Sweden
Duration- 6 months +
LANGUAGE - ENGLISH & SWEDISH FLUENT SPEAKER
JOB REQUIREMENT:
o Must speak Swedish and English
o Minimum 5 Years quality assurance/pharmaceutical experience
o Pharmaceutical operations knowledge
GMP and QA system background relating to computer systems.
GMP regulations including EU, US-FDA
Good Automated Manufacturing Practice - GAMP 5.0
Assessment of computer validation approaches and electronic records
EXCELLENT WORKING KNOWLEDGE OF:
EudraLex Annex 11, 15
US - CFR's 210 & 211 GMP
US - CFR's Part 11 Ruling
US - CFR Part 11 Revised Scope
GAMP 5.0 All chapters
Risk Based Approach for Computer Systems
Fundamental understanding of Sarbanes Oxley Data Security 404
Location- Södertälje, Sweden
Duration- 6 months +
LANGUAGE - ENGLISH & SWEDISH FLUENT SPEAKER
JOB REQUIREMENT:
o Must speak Swedish and English
o Minimum 5 Years quality assurance/pharmaceutical experience
o Pharmaceutical operations knowledge
GMP and QA system background relating to computer systems.
GMP regulations including EU, US-FDA
Good Automated Manufacturing Practice - GAMP 5.0
Assessment of computer validation approaches and electronic records
EXCELLENT WORKING KNOWLEDGE OF:
EudraLex Annex 11, 15
US - CFR's 210 & 211 GMP
US - CFR's Part 11 Ruling
US - CFR Part 11 Revised Scope
GAMP 5.0 All chapters
Risk Based Approach for Computer Systems
Fundamental understanding of Sarbanes Oxley Data Security 404
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management