CSV Manager Barnard Castle, England
Job description
Posted Date: Feb 16 2023
This role will be site based at UK, County Durham, Barnard Castle and will offer flexible working for the right candidate.
As the site’s Computer Systems Validation Manager, you will provide leadership of the CSV Validation Team, setting the strategic direction of Quality Assurance and Validation for controls and IT projects. You will provide effective leadership of quality personnel, to establish processes and controls that meet Regulatory, cGMP, and Quality Management System standards.
In this role you will…
- Be the Site’s CSV subject matter expert to ensure compliance with GAMP, 21 CFR Part 11, Annex 11 and Data Integrity requirements on all systems.
- Lead the team accountable for the validation and validation maintenance of computerised systems associated with Processes, Facilities, Equipment, Manufacturing Execution Systems (MES) and IT systems.
- Support emerging digital and data analytics projects, providing guidance on novel approaches to validation
- Contribute to companywide QMS improvements and lead the development of site QA and Validation standards and procedures for controls and IT systems
- Work collaboratively with teams and cross functional stakeholders across the organization, forming strong partnerships (on and off site) at a technical level, providing QA compliance leadership
- Use your experience and knowledge in active risk management and problem solving to make rational, risk-based decisions which are communicated clearly to stakeholders
- Support the development and training of your direct reports, to maintain a high performing team that are forward thinking to achieve results and protect productivity, whilst remaining compliant.
- Provide coaching/training in CSV to staff within the wider Validation, Quality and Engineering departments.
- Ensure project planning processes are used to balance resources, and minimise impact on existing operations
- Deputises for the Quality Lead where required at functional, site and above site meetings.
- 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 or a demonstrated track record in the pharmaceutical industry.
- Specialisation in Quality Assurance, Validation or IT/Engineering
- Extensive experience of several different types of computer system validation e.g. IT, Controls, Laboratory, Spreadsheet and Bespoke software validation as well as deployments of above site systems to a site.
- Practical experience working to compliance of GAMP, 21 CFR Part 11, Annex 11 and Data Integrity
Why GSK?
Uniting science, talent, and technology to get ahead of disease together
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.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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