As an established and trusted partner for end-to-end integrated engineering, quality and management for digital transformation, my client is working through a strategic expansion into the life sciences sector. This has resulted in a new role for a consultant specialising in CSV Engineering.
This contract will initially be offered for 12-months with the potential to extend thereafter. Given both their existing customer demands and new client requirements this department will continue to grow over the coming months.
You would be joining a team of 500 staff in Ireland with a global network of over 15,000 employees.
- Work directly with clients to complete gap analysis and conduct assessments to scope the requirement in full.
- Design, generate and execute CSV plans and test protocols, managing and reporting findings and non-conformances raised during testing.
- Ensure systems and their associated documentation are fully compliant with site specific policies and regulations, GMP and industry regulations.
- Ensure completeness and consistency of validation life cycle documentation for computerized systems used to control, monitor and manage data.
- Maintain accurate validation documentation across client accounts.
- Manage the resolution of fundamental CSV compliance issues derived from implementation of 21 CFR Part 11 automated controls in legacy systems.
- Ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance with requirements.
- Educated with a 3rd level Degree in a technical discipline.
- Minimum 5 years working in a GMP/GDP operation.
- Demonstrated ability to lead a project team of consultants within a client facing environment.
- Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Reporting).
Competitive hourly rate offered for an initial 12-month contract.
For more information and a confidential discussion please contact Aisling Clements on +353 87 752 1041