Description
We are looking for a
Computer Validation Specialist / GMP Consultant (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Thuringia
Branch: Erbringung von Dienstleistungen der Informationstechnologie
Your tasks:
- 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
Your qualifications
- 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
Skills:
- IT consultant
Keywords: GMP GxP GAMP Computer Validation ICH Q10 ICH Q9 CFR CFR’s 210 & 211 GMP