The IT Quality Specialist is an exciting and integral role within the company and will act as subject matter expert on IT Quality processes and Computer systems validation to ensure compliance with company CSV policy, Annex 11, GXP, 21 CFR part 11 and Data Integrity guidance.
The major activities of this role would be:
- Act as IT QA and CSV SME on a range of IT system implementations, producing validation deliverables across full SDLC lifecycle.
- Act as IT Quality lead in supplier audits
- Maintain the IT system inventory ensuring that all information is current and accurate.
- Subject matter expert on IT quality policy and processes, act as the main point of contact between IT and the business on resolution of compliance questions and clarifications.
- Regular review of existing IT Quality policy and process and documentation
- Complete Periodic Reviews for a range of different system types
- Identify and perform risk assessments on all IT infrastructure, applications and support processes, documenting and resolving any findings
- Produce Monthly quality service metrics report and present to Business Quality functions as required.
- Previous experience of working within a GxP environment such as Pharmaceutical or Medical services
- Exposure to working with Quality Management Systems, specifically EU Annex 11 and/or 21 CFR part 11.
- Experience in following CSV guidelines such as GAMP5 and Data Integrity
- Exposure to or awareness of quality management process such as ISO9001 and ISO27001.
- Ability to coordinate complex tasks within the IT function and business as appropriate, including developing plans, coordinating resources, resolving issues and maintaining compliance to all relevant standards and methodologies.
- Good / Strong English language skills (written and spoken)
- Proven capability in writing documentation
- A good understanding IT Technologies
- Awareness/Certification in ITIL processes.
- Proven communication skills are essential in this role
- Competitive salary
- Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
- Multicultural environment, English as a company language
- Strong emphasis on personal and professional growth
- Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year