Description
IT Quality and Validation consultant - CSV - SOPS - Barcelona area - Spain
NextLink is having an existing position as IT Quality and Validation consultant for global projects in Barcelona, Spain.
Service characteristics
- Title: IT QMS & Quality Validation Service
- Location: Barcelona area
- Period: 10 months (until 31.12.2017)
- Desired start date: February
- Travel: Some
Service description
Support the IT Quality Validation & Governance Team in the defining the strategic framework for the client IT QMS:
- Challenge existing policy and procedures to develop a lean and fit for purpose QMS
- Work with IT Quality Lead and Process Owners to define Policies & Procedures
- Engage and collaborate with other client IT service providers/vendors to identify dependencies and develop policies and procedures.
- Review IT SOPs (Standard Operation Procedures) for regulatory compliance
IT Quality and Validation support for IT owned and IT enabled application, solution, and infrastructure projects:
- Create quality related documentation on an as needed basis ( validation and qualification plans, deviation reports)
- Escalate issues and risk management/mitigation
- Collaborate with team leads and PMs on ensuring compliance to CSV (Computer System Validation) guidelines & Regulations
- Collaboration in the creation and delivery training for GxP compliance
Must haves
- Mid-level QA quality analyst with in-depth knowledge of IT Quality processes and governance eg GAMP 5 and ISO 13485
- Experience writing SOPS and designing processes in a complex, fast paced environment
- Experience with Electronic Document Management Systems
- Experienced with MS Word, MS Powerpoint, and Visio
- Proficient English language skills and experience working on a global cross-cultural team
Nice to have
- Experience in Pharma industry
- Fluent in German, Spanish, French
Service deliverables
- Review & creation of client IT SOPs (ITSM/IT Processes/Document Management)
- QMS & ISMS: Identification all required SOPs + Review all required SOPs
- Quality related documents: Validation/Qualification Plans & Reports to write + Deviation reports to write
- Review of Project documentation: CSV Documents + Change requests (review of impact analysis, approval of CR phases)
- EDMS libraries: structure and workflows management
For a chance to work in Spain asa IT Quality and Validation consultant please call me or send your CV and I can call you.
Leila Benabdallah
IT sourcing specialist