Title: Senior Quality Control
Location: GSK Ware
Pay Rate: £37.00 Per Hour / Via Umbrella / Inside IR35 / PAYE Option is available
LOA: 5 Months
Quality Coordinator Senior level 2
The Quality Coordinator role promotes quality and compliance throughout GSK’s Research and Development (R&D) process. This entails monitoring all quality related systems, improvement procedures and documentation (including analytical data and information), ensuring that quality is not impacted with respect to regulatory and cGMP requirements.
As the Senior Quality Coordinator you will be responsible for performing the quality assurance activities and quality oversight of the GMP (Good Manufacturing Practice) functions performed within GSK’s Pharmaceutical R&D functions at our R&D sites. Your home site will be Ware however we support Stevenage, Cambridge, Harlow and travel to these sites may be required. In addition you may be asked to support our two US sites. This will be remote support if that is the case.
Our groups role is the QA oversight and support for utilities, facilities and validation at the UK sites mentioned above with support of our US team when required.
The role will involve the QA oversight across R&D sites within our remit of;
· Change control.
· Deviations, vendor complaints and associated CAPAs.
· You will be expected to participate in root cause analysis of deviations as a QA person to ensure GMP impact is considered and recorded. This ensures that they are fully investigated such that appropriate steps/measures are assigned and the risk to product quality and compliance is fully assessed.
· Validation across different business areas inclusive of analytical equipment, pilot plant equipment, computerized systems, utilities and facilities. This will involve protocol review and approval as well as QA consultation when required.
· Data change approval within our CMMS system of utilities and facilities, of which we have oversight.
Throughout your day-to-day work you will promote quality and compliance, including monitoring of improvement activities where applicable.
The role includes a strong focus on raising collective performance and continuous quality improvement. As part of the quality assurance team, you will actively promote team working and effective communication across the Ware R&D site but also across GSK’s wider Quality functions (at other sites).
You will be an experienced Quality Assurance person with relevant experience in validation, deviation and change control management.
Good knowledge and application of regulatory expectations in the EU/UK and FDA markets.
Corresponding good knowledge of current Good Manufacturing Practice requirements.
Ideally with an engineering background and a minimum of two years experience in the above.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com