Quality Assurance Associate

Do you want to be a part of a team that gives hope to patients living with rare and life-threatening diseases? WEP Clinical partners with physicians, hospitals, drug companies and industry to provide early access to the medicines patients need when they need them the most. Join our team and help transform patient lives.

Role Objectives:

The WEP Clinical Quality Assurance Associate will ensure compliance with relevant Good Distribution and Manufacturing Practices for the importation, storage, and supply of medicinal products by utilising knowledge of the WEP Quality Management System. The role will support the wider Quality team in driving the completion of day-to-day quality tasks.

The ideal candidate for this role is:

• Proficient in both written and oral communication, with a focus on effectiveness.
• Highly self-motivated and possesses strong interpersonal skills.
• Pro-active and solutions-driven, adept at managing multiple tasks and deadlines with precision.
• Capable of identifying and escalating issues to management or stakeholders as needed.
• Able to handle highly confidential information discreetly and responsibly.

Essential Job Duties and Responsibilities:

• Responsible for ensuring that a compliant quality system is maintained.
• Responsible for ensuring GMP and GDP compliance and best practices within all such regulated activities.
• Responsible for ensuring that operations do not compromise patient safety and the quality of supplied medicines.
• Assist in maintaining a strong Quality culture throughout the UK and EU.
• Provide day-to-day support for business-wide quality enquiries.
• Support the Quality staff to ensure GxP Training is up to date and assist with SOP training.
• Assist in the creation, maintenance and archiving of GxP documentation.
• Contribute to deviation investigations and follow up on CAPAs to ensure timely close-out of actions.
• Log Complaints and support timely investigation and record resolution.
• Contribute to the self-inspection schedule as a supporting auditor.
• Undertake customer, supplier and vendor approvals, including periodic requalification.
• Prioritise emergency orders

Qualifications:

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• Knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and MHRA Guidance Note 14
• Basic knowledge or exposure in a Quality related role
• Practical experience in GxP Supply Chain, Production, and Quality Assurance
• IT literate: Microsoft Outlook, Word, Excel
• Practical experience and knowledge of warehousing and logistics processes in a GDP environment is preferred