Job Reference: FRS37740
Job Duration:
Start date: 26/05/2020
Description:
QA IT, Newcastle UK
Pharmaceutical Site
My client is a market leaderin manufacturing solutions within the Biopharma & Pharmaceutical industries and they are looking for an experienced QA IT /CSV Engineer to join their expanding teams, based on a pharma site near Newcastle in the UK
Can avail of salaried option or contractor rate. 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 supportroutine and project CSV activities, including upgrades of existing process control and laboratory systems.
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
Requirements:
* Relevant Degree Qualification* Min. 5 years of experience in QA IT/CSV, CSV in a similar role in the pharmaceutical industry
* Expert knowledge of relevant regulations and industry standards.
* Shopfloor integration, MES, Packaging, AIT & PAS-X experience will be an advantage.
* Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
* Excellent communication skills.
*Project management experience will be an advantage.
CLICK APPLY NOW for more information about this amazing opportunity.
Industry: Engineering
Salary:
Salary Benefits:
Vacancy Type: Permanent
Job Skills: CSV, VALIDATION, QUALITY VALIDATION, PHARMA
Contact Name: Dara Bradley
Website: -
Direct Application URL: -