QA Specialist, IT
The Senior QA Specialist IT will be responsible for performing key Quality tasks with a focus on IT projects. Work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, IT projects, select supply chain operations and development functions as well as internal Quality Systems.
Reporting to the Associate Director of Quality.
Responsible for developing and maintaining Quality Systems and to ensure that all operations are fully in compliance with current international standards for cGMP.
Review & approval of validation protocols and reports related to Computer system/software validation
Ensure continuing compliance of in-house qualified systems
Keep abreast of current industry standards and best practices for hardware and software qualification/validation
Act as QA lead for IT related risk assessments, investigations and change controls
Conduct internal audits and/or support external vendor audits as required
Develop and write SOPs and controlled documents.
Develop and report Quality Metrics as required
Work closely with other key Company departments to ensure delivery of key project objectives and timelines.
Work directly with other key Company departments to ensure compliance and productive working relationships.
Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
Contribute to management of the supplier approval programme and to maintenance of the external audit schedule.
Assist with troubleshooting quality issues at Partner?s or vendor?s site or associated with technology transfer, when required.
Supporting regulatory submissions
Bachelor?s degree in chemistry, biology, computer science or a related discipline.
Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
Experience with Computer system/software validation and GAMP 5 practices
Thorough understanding of Quality Systems, cGMP?s including 21 CFR part 11and Annex 11
Experience with third party vendor auditing, out of spec investigations, change control.
Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
Experience interfacing with regulatory bodies, has participated in regulatory inspections or working on regulatory submissions
For further information on this QA Specialist IT position please contact Laurentina Kennedy at
The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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