QA IT Specialist

Employer
Zentek Engineering Limited
Location
Cramlington, UK
Salary
Competitive
Closing date
10 Oct 2020

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Sector
Technology & New Media
Contract Type
Permanent
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QA IT Specialist JO1721

Location: Cramlington

Fixed term for 12 months

Delivering MES, Automation and Process Control Excellence

Zenith Technologies operate primarily in Life Sciences; we are world leaders in delivering manufacturing software systems that make businesses compliant and competitive. We specialise in providing Enterprise Performance Solutions comprised of MES, Automation and Process-Control to Life Science companies globally. Working with 9 out of the Top 10 Pharmaceutical and BioTech companies, we partner with customers as an independent trusted advisor, providing performance improvements, reduced costs, total compliance and improved operator effectiveness. We achieve this through combining experienced engineers and consultants, comprehensive design methodologies, and leading edge technology implementation.

"Innovation and change, Join ZT"

The successful candidate will join the site QA IT team on a fixed term basis for 12 months 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.

Main Responsibilities:

·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.

Desired Background/Experience/Attributes

·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.

·Experience with packaging lines.

·Project management experience will be an advantage.

·PCS and PAS-X experience will be an advantage.
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