- BSc in science, maths, automation or computing. (Or equivalent international qualification)
- Significant experience in the Pharmaceutical or other regulated industries.
- Excellent verbal and written communication skills, with the ability to communicate internally at production operator to site director level and externally from vendor to regulatory auditor level.
- Structured analytical approach to requirements gathering and problem solving.
- Project Definition, Launch and Management skills.
- Capable of working in multi-disciplinary teams across sites, IT, new product introduction and technology.
- Knowledge of Pharmaceutical or Medical Device cGMP and regulations, for both EU and US regulatory standards.
- Broad knowledge and practical experience of computer and application validation, cGMPs, and 21 CFR part 11 strategies.
- GMP manufacturing knowledge and experience of associated data and analysis techniques.
- Manufacturing source system knowledge (Data historians, laboratory systems, Aspen Manufacturing Suite, OEE, SAP, IP21).
- Knowledge of manufacturing and R&D data sources and data structures including Analytical, Batch and Continuous data structures.
Site Informatics Expert
GSK is a science-led, global healthcare company that produces innovative medicines, vaccines and consumer healthcare products.
Our global manufacturing and supply (GMS) teams are responsible for making and shipping the products that help people do more, feel better, live longer. We have more than 27,000 people in GMS, across 86 sites in 36 countries. Together, these people help to produce 4 billion packs of medicine, nearly 900 million doses of vaccine and more than 18 billion packs of consumer healthcare products every year
Are you a technical professional who wants to make a difference?
We’ve got a great new permanent full-time opportunity as a Site Informatics Expert to join the New Product Introduction and Process Technology (NPI-PT) team at our key manufacturing and NPI site in Barnard Castle.
All GSK production processes must be validated and continuously monitored to ensure that they remain capable of producing safe, effective and cost efficient products. This presents a technical challenge to the Barnard site as data is generated by a variety of automated, semi-automated and manual processes. Improving our effectiveness at acquiring, manipulating and analysing this data is a key priority.
We are looking for an individual who can rapidly assimilate background information relating to GSK processes and how they are monitored and controlled. The Site Informatics Expert will work to bridge the technology gap between existing data systems and the Product Family Owners, Site Statistical Team and Quality Assurance function.
The impact of the role is broad and significant. There are huge implications in terms of how informatics keeps the business running to supply our patients but also it can have a huge impact in simplifying the business and creating value through continuous improvement.
Want to be Part of a High-Performing Team?
As Site Informatics Expert, you will be part of GSK Barnard Castle’s expanding NPI-PT Technical Team. The goal of the Technical function is to deliver scientific expertise to the manufacturing processes and technologies, ensuring our new and existing products are in a constant state of control.
The team is critical to ensuring the site’s complex manufacturing processes are controlled and robust for all dose forms across a range of different pharmaceutical product streams.
As Site Informatics Expert you’ll be responsible for:
• Defining data acquisition strategies for new and existing products. This will be accomplished by liaising with Product Family Owners who have committed to process monitoring as identified in technical risk assessments and product control strategies.
• Maintaining an overview of the existing and forthcoming data gathering systems. These include IP21, LIMS and SAP.
• Providing “voice of the customer” input into forthcoming data acquisition systems.
• Deploying existing or new technical skills to facilitate the migration of data between acquisition systems, spread sheet and statistical analysis software.
• Working alongside NPI-PT and Quality colleagues to identify opportunities for better knowledge-led continuous improvement.
• Devising and delivering training in the use of data systems and the interpretation of data.
• Promoting and facilitating site self-sufficiency in the acquisition and manipulation of process data.
What’s on offer?
Our reward package includes:
• A competitive base salary with an annual bonus that rewards you for your individual contribution to our strategy, as well as business targets.
• Benefit programmes designed to support you and your family, including access to healthcare and well-being programmes, pension plan membership, savings programmes, time off and childcare support.
• Employee recognition programmes which reward exceptional achievements.
• Share ownership schemes which link your reward to GSK’s longer term performance
• A performance and development programme that helps you identify what you need to do, and the behaviours you need to demonstrate, to achieve success
Interested in join the team?
Please apply via our online application system the latest on 2nd June, COB
If requiring an adjustment for a disability, once selected for interview you may contact firstname.lastname@example.org
Help us knowing more about you by using the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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