Computer Systems Validation - Barnard Castle, United Kingdom - GSK

GSK

Verified Company

Barnard Castle, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Site Name:
UK - County Durham - Barnard Castle

Posted Date:
Jan

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics.

We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 million vaccine doses in 2021.

We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service.

The way we work will change. For some, the shift in technology and products will be revolutionary.

Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

_ Job Title_
Computer Systems Validation (CSV) Specialist

As a Computer Systems Validation Specialist, you will provide QA and Validation support to automation and IT projects.

You will provide technical advice and take quality decisions to establish processes and controls that meet Regulatory, cGMP, and Quality Management System standards.

_ In this role you will_

Be accountable for the validation and validation maintenance for computerised systems associated with Processes, Facilities, Equipment, Manufacturing Execution Systems (MES) and IT systems.
Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives.
Provide oversight of Quality Assurance processes within projects e.g. change control, validation documentation, deviation handling, CAPA.
Work collaboratively with teams and cross functional stakeholders across the organization, forming strong partnerships (on and off site) at a technical level.
Interact, influence and negotiate with peers and all levels of management, providing QA compliance leadership.
Use your experience and knowledge in active risk management and problem solving for both new and existing systems.
Analyse complex data, information and scenarios to make rational, riskbased decisions which are communicated and / or escalated clearly and confidently.
Support a continuous improvement culture.

Our Global Supply Chain (GSC) business is responsible for making and supplying our pharmaceutical and biopharmaceutical products around the globe.

The GSC organisation is involved with every production stage from the infrastructure of the manufacturing sites, supply forecasting, regulatory inspections, and the product's quality.

_ Why you? _

Qualifications & Skills:

Graduate level qualification in a relevant degree preferred and/or a demonstrated track record in the Pharmaceutical, Chemical or Engineering industry
Previous relevant experience of controls, automation and/or IT systems
Knowledge and understanding of GAMP, 21 CFR Part 11, Annex 11 and Data Integrity
Ability to work well under pressure with tight timelines

Preferred

Qualifications & Skills:

Degree in a Science, Engineering or Computer Science related discipline
Experience in Validation, Quality Assurance and/or Production Processes
Practical experience working to compliance to GAMP5, 21 CFR Part 11, Annex 11

_ Why GSK? _

Uniting science, talent, and technology to get ahead of disease together

_ Why GSK? _

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Find out more:
Annual Report 2021

Getting ahead means preventing disease as well as treating it, and we aim to impact th