Senior IT Quality Specialist

  • Full-time
  • Department: IT

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.  

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia 

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.  

We have nourished a true international culture here at Ergomed.  

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.  

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

Job Description

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.

Qualifications

  • 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

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

 We offer: 

  • Training and career development opportunities internally  

  • Strong emphasis on personal and professional growth 

  • Friendly, supportive working environment 

  • Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!  

Quality 

Integrity & Trust  

Drive & Passion  

Agility & Responsiveness  

Belonging 

Collaborative Partnerships  

We look forward to welcoming your application.

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