I am working with a mid-sized pharmaceutical company based in Berkshire who is looking for a Supplier Assurance Specialist who will join their high performing Global Quality team.
The role will contribute to the management and maintenance of my client's quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate and that my client fully complies with all relevant legislation and industry recommended practice.
The ideal candidate will have the following experience:
* Management of suppliers and service providers ranging from manufacturing and automated packaging to distribution activities throughout Europe.
* Provide support to other functions within the Global Product Quality team, such as:
* Supporting the Quality Control Laboratory
* Batch record reviews
* Management, monitoring, review and approval of Change Controls, Deviations, CAPAs and PQCs
* Conducting training sessions on Quality processes
* Providing support to regulatory inspections
* Artwork approvals
* Serialisation solution in relation to the Falsified Medicines Directive
Functional & Technical Competencies for this position are:
* High attention to detail
* Very good written and spoken English
* Excellent time Management & organisational skills
* Ability to pro-actively identify issues and seek resolution
* Experience in management of GMP/GDP Quality Management Systems
* Additional relevant QA experience
* Excellent written and verbal communication skills
* Ability to learn quickly and adapt quickly to changing requirements
* Ability to work to tight deadlines
* Good problem solving skills
* Must be able to handle sensitivity and confidentiality levels appropriately.
* Ability to negotiate with third parties on Quality processes
* Based at the Europeon office, with significant travel, mainly in Europe, but also in Asia and North America.