LSC have a great contract opportunity for an IT Quality Assurance Specialist to join a leading biotech company based in Meath.
If you have at least two years of experience in a similar role and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Collaborating with stakeholders (e.g., System Owners, Process Owners, Data Owner and MMD IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
- Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports, and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
- Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g., problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
- Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
- Driving resolution of regulatory non-conformance for GMP computerized systems.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- At least two years of experience in delivering validated IT solutions or an application support role.
- Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
- Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
- Must demonstrate working knowledge of the principles, theories, and concepts of computerized system validation / compliance.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Paul O' Driscoll on 0214777329 if you have any more questions about this opportunity