Computer Validation Specialist / GMP Consultant (m/f)

Job type:
Start date:
12 MM
Hays AG
Published at:
flag_no Germany
Contact person:
Kerstin Sieber
Project ID:

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We are looking for a
Computer Validation Specialist / GMP Consultant (m/f)

Reference: 228812/9-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

- IT consultant

Keywords: GMP GxP GAMP Computer Validation ICH Q10 ICH Q9 CFR CFR’s 210 & 211 GMP