QC Coordinator - Change Control
- Harlow, Essex (GBR)
- £22 - £29 Per Hour
- 10 Months
- Start date: ASAP
- Ref: GSK0JP00095386
- regulatory
- quality assurance
- validation
- fda
- change control management
- good manufacturing practice
Quality Coordinator
Harlow / Remote
Contract until March 2023
Up to £22 per hour PAYE / £29 per hour via Umbrella
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.
Job Purpose:
As the Senior Quality Coordinator you will be primarily responsible for performing the quality assurance activities and quality oversight of the GMP (Good Manufacturing Practice) functions overseeing the implementation (via change control) of a new pack, label and distribute computerized system into the GSK’s Pharmaceutical R&D functions at our R&D sites. Your home site will be Harlow however this system will also be used to support R&D activities at Zebulon (US) and Dublin (Ireland) working with team members from a variety of GSK R&D sites (not limited to the above mentioned - remote support only required for non-UK sites).
You will be working with the project implementation team as a member of the QA group, overseeing the documentation and implementation of the business change to their processes
It is a fantastic role that offers a wide range of development and progression opportunities depending on your passion.
The role will involve the QA oversight across R&D clinical supply chain activities for the implementation of the business processes associated with the new computerized system (e.g. warehousing/logistics, packaging/labelling, QA release etc.) within the main focus of;
• Change control action plan definition, QA review and approval for the business implementation of the system.
• Provide advice and support to business partner areas relating to quality matters and process improvement.
Your role may also involve supporting the other QA oversight activities which the CSC-QA team manage:
• Supporting the QA team overseeing investigational medicines batch release activities, including customer/vendor complaints and Deviations/CAPA
The role includes a strong focus on
• Raising collective performance and continuous quality improvement.
• Strong attention to detail, problem solving skills and ability to learn new skills and apply them.
• Good communication skills with the ability to build relationships and trust; and to be able to make decisions based on GMP principles
• Experience working in high pressure environments where there are likely to be conflicting priorities
About You:
You will be an experienced Quality Assurance person with relevant experience in validation 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 having a minimum of two years’ experience in the above.
