PrimeVigilance is continuing to expand and is looking for an IT QA/CSV Associater to join our dynamic and rapidly growing organization.

The IT QA/CSV Associate will act as Subject matter expert on IT Quality processes, (Computerized Systems Validation, GXP, 21 CFR part 11 etc.), striving to improve on existing IT quality processes to ensure that the IT function delivers secure, robust and compliant systems and services.

• Act as IT lead in supplier audits
• Advise on IT quality processes when required
• Act as Liaison between IT and Business Quality functions on all aspects of quality.
• Regular review of existing processes and documentation, Identify gaps against requirements then author (or delegate) and implement for all processes and services.
• Operate, Review and maintain Quality processes in support of Computerized Systems Validation and qualification such as Periodic Review, Change Control,   Incident / Problem management, IT CAPA
• Review and audit third party suppliers in line with supplier qualification and periodic review processes
• 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 Pharmaceutical / Medical services company
• Exposure to working with  Quality mManagement sSystems, specifically GxP 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

Our Offer

• 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