Computer Validation Specialist / GMP Consultant (m/f)

-Ensure the computer projects meet regulatory requirements of GMP regulations
-Ensure computer lifecycle approaches are suitable to regulation and risk approaches
-Ensure suitable risk assessment practices across computer lifecycle
-Ensure suitable risk assessment practices for Electronic records and signatures
-Ensure computer lifecycle deliverables are created in accordance with GAMP best practice
-Ensure operational project hand over of computer systems are clearly organised
-Assessment of computer system regulatory risks against the requirements of GMP regulations
-Perform and document risk assessment and gap analysis
-Establish validation planning including approach, deliverables, team responsibilities
-Create validation and quification lifecycle deliverables
-Review and approve supplier documentation
-Provide clear communication to project teams on validation approach and deliverables
-Provide regular project reporting
-Develop and support client operational procedures for computer system validation
-Develop and support client training for computer systems validation
-Ensuring traceability acorss validation deliverables
-Ensuring good document management practices are followed
-GMP and QA system background relating to computer systems
-GMP regulations including EU, US-FDA
-Good Automated Manufacturing Practice – GAMP 5.0
-Management of computer development lifecycle and validation approaches
-Assessment of computer validation approaches and electronic records
-Excellent communication abilities (English speaking)
-Excellenet working knowledege 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 and Risk Based Approach for Computer Systems -Quality assurance / pharmaceutical experience
-Pharmaceutical operations knowledge

Weitere Qualifikationen: IT consultant