Job Description:
As the Responsible Person (RP) in our European wholesale distribution operations, you will play a critical role in ensuring compliance with regulations and maintaining the highest standards of quality.
The successful candidate will be responsible for acting as the RP for a European wholesale operation, as well as serving as the Designated Person responsible for importation, storage, and distribution activities for active pharmaceutical ingredients (APIs) distributed in the EU.
You will also serve as the Deputy RP on any of the Wholesale Distribution Authorisations (WDAs) as required, supporting the maintenance and management of Quality Assurance Agreements to ensure Trading Partner business operations within the EU comply with standards.
Additionally, you will uphold and maintain the Trading Partner function to comply with the GSK Quality Management System, supporting TPQ projects related to worldwide distribution operations as needed.
Key Responsibilities:
* Acting as the Responsible Person for a European wholesale operation
* Acting as the Designated Person responsible for the importation, storage, and distribution activities for APIs distributed in the EU
* Serving as the Deputy RP on any of the WDAs as required
* Supporting the maintenance and management of Quality Assurance Agreements to ensure Trading Partner business operations within the EU comply with standards
* Upholding and maintaining the Trading Partner function to comply with the GSK Quality Management System
* Supporting TPQ projects related to worldwide distribution operations as needed
Requirements:
* Third-level qualification in a scientific discipline or demonstrated equivalent level of knowledge
* Experience in a regulated pharmaceuticals environment
* At least 2 years' experience in a Quality Assurance role, including experience in the application and improvement of quality management systems
* Knowledge of WDA(H) and MIA licences, Active Substance Registrations, Controlled Drug and Precursor Chemical licences
Preferred Qualifications:
* Degree in Pharmacy, Chemistry, Biology, or equivalent experience