Ergomed is a rapidly growing  global clinical research company.  We perform clinical trials  for rare and complex diseases.

The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Due to continued growth, we are seeking a Computer Systems Validation/IT QA Specialist

The CSV / 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.
• Provide support in supplier audits
• Maintain the IT system inventory.
• Subject matter expert on IT quality policy and processes.
• Complete Periodic Reviews for a range of different systems.
• Perform IT quality risk assessments on IT infrastructure and applications.
• Produce Monthly quality service metrics report.

• Previous experience of SDLC, testing, and validation within a GxP environment within the Biotech/Pharmaceutical Industry
• Desired knowledge of Good Clinical Practice (GCP) and  Good Pharmacovigilance Practice (GvP) applicable regulations and guidance related to computerised systems.
• Knowledge of 21 CFR Part 11, Annex 11, and GAMP 5. Awareness of ISO9001 and ISO27001.
• Good technical IT knowledge.
• Experienced in IT System/Software Development Life Cycle (SDLC), change controls, validation, and quality processes.
• 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