QA IT Specialist - Cramlington, United Kingdom - JO1721
Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.
Operating across 5 continents and with over 850 skilled employees, Zenith partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimisation and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.
We’re looking for dedicated, innovative and driven talent to join our expanding team.
“Innovation and change, Join ZT”
About the Role:
The successful candidate will join the site QA IT team to provide independent oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. The QA IT specialist will support routine and project CSV activities, including upgrades of existing process control and laboratory systems.
* Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for new and modified systems.
* Providing independent quality review and approval of system changes.
* Supporting and approving computerised systems investigations and deviations.
* Ensuring consistent approach to qualification, change and deviation management across systems and projects.
* Managing and prioritising day-to-day activities through active alignment with the assigned projects and business areas, and supporting other areas as needed.
* Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
* Where required, engaging with QA IT teams from other sites to standardise and align approach to computerised systems compliance
* Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
* Expert knowledge of relevant regulations and industry standards.
* Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
* Excellent communication skills.
* Project management experience will be an advantage.
* Shopfloor integration and MES PAS-X experience will be an advantage