Description
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