Job Description
Site Name: UK - Hertfordshire - Ware
Posted Date: Feb 12 2025
The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all quality related systems, improvement procedures and documentation (including data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets).
Job Purpose:
A Qualified Person (QP) reviews and certifies finished products (batches) for release/onward progression (to market). QPs are responsible for ensuring that batches are manufactured in compliance with laws (for all the Member State where certification takes place) and in accordance with the requirements of marketing authorization (MA). All released products must conform to required quality standards (by reviewing appropriate documentation) and have been manufactured and packaged according to the regulatory dossier, Good Manufacturing Practice (GMP) and business requirements.
In delivering the role, the QP takes informed decisions on the suitability of products to be released. This includes completing SAP activities (to allow release of batches for further processing or shipment) and ensuring deviations from GMP (or company standards) in manufacturing/packing operations are fully recorded and investigated. This element of the role extends to appropriate steps/measures (CAPA) being assigned and any risk to product being fully assessed. You will also provide oversight of change-control, complaint, distribution, self-inspection and other key processes within site’s Quality Management Systems (QMS). Throughout your day-to-day work you will promote quality and compliance, including monitoring of improvement activities.
The role has a strong focus on raising collective performance and continuous quality improvement. As a member of the quality assurance team, you will promote team working and effective communication across GSK’s wider Quality functions (across multiple sites). You will also deputise for the Quality Managers in completion of QA approval of key site documents (eg; deviations, Standard Operating Procedures (SOPs), technical reports, etc).
About You:
You will be a Qualified Person (QP) – this is key to delivery in this role. Your QP qualification must be recognized in the UK.
As this role is multi-faceted and collaborates with a wide variety of on-site production and operations teams, you will also be self-motivated with strong experience of working in quality at a sophisticated manufacturing site. You will be resilient and calm, with strong communication skills.
Please Note: The role is a site-based role.
Basic Qualifications:
* Qualified Person (QP) stated on a current UK Manufacturer’s/Importer’s licence
* Relevant experience
Benefits:
GSK offers a range of benefits to its employees, which include, but are not limited to:
* Competitive base Salary
* Annual bonus based on company performance
* Opportunities to partake in on the job training courses
* Opportunities to attend and partake in industry conferences
* Opportunities for support for professional development/chartership
* Access to healthcare and wellbeing programmes
* Employee recognition programmes
* Hybrid (onsite/remote) working within GSK policies (post training period)
CLOSING DATE for applications: Wednesday 19th of February 2025 (COB).
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