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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Senior CSV Specialist- Hybrid


Reference:/RH/AWIO-738258 Location: Republic of Ireland
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Validation Specialist, Validation Engineer, Validation Coordinator

Life Science Recruitment is hiring for aSenior CSV Specialist to join our clients expanding Life Sciences division.You will join our high-performance team of Technical Engineers and work within an expanding team providing cutting-edge solutions to clients. You will work collaboratively with our customers to scope, plan, implement and refine solutions specific to requirements.

Responsibilities:

  • Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech)
  • Work directly with our clients to perform gap analysis / early engagement assessments to understand the required scope of full assessments
  • Conduct CSV Assessments / Health Checks to assess compliance and report back to senior stakeholders with findings and suggested solutions
  • Resolution of fundamental Computer System Validation (CSV) compliance issues derived from implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems
  • Ensure all project related issues and deviations are documented and approved
  • Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards.
  • Review and approve documents prepared by project teams, other departments and contractor organizations
  • Assist in development of validation strategy and validation plan for computer system validations.
  • Assist with change control activities in accordance with site procedures
  • Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with system changes and new technology development.



Qualifications and Experience:


  • Relevant third level qualification or equivalent work experience
  • Above 8 years’ Computer System Validation experience including lead experience
  • Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Reporting)
  • Ability to lead a team of CSV consultants in a consulting environment



Skills:


  • Client-facing skills
  • People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
  • Team work and emotional intelligence
  • Good self-management – continuous performance is both an objective and a mind-set
  • Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
  • High value on openness and transparency



Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required.
No visa sponsorship will be offered with this role.

Call Ruth Holland on 087 7822 198 for more details.