Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

 Position Summary:

The QP will provide support to all appropriate and relevant activities within Fisher BioServices, UK.

The job has three primary functions, QP certifications and declarations, technical contribution to the operations of FBS UK and conducting audits.

The jobholder will form part of the ‘Quality team’, supporting the QP certification activities, maintaining an up to date awareness of current legislation and contributing to QP policies.

Key Responsibilities:

• To provide QP certification in compliance with regulatory requirements and if required, specific client technical agreements.• To perform QP GMP declarations including on site audits if required, in support of importation activities.• To perform UK QP Oversight activities.• Conducting internal and external audits as required.• Provision of GMP training.• To provide information and training on the QP roles and responsibilities to FBS personnel.• Where needed, support Business Development/Sales and Project Management at pre-contract stage to assess new contracts.• To maintain awareness the regulatory issues affecting the clinical supplies process keeping relevant FBS colleagues informed where appropriate.• To provide technical advice and support in the preparation of Technical Agreements.• Support client and regulatory audits with QP input.• May be required to perform off site work where necessary.• Travels as required.

Minimum Requirements/Qualifications:

• Meets the UK requirements for Qualified Person status.

 Hiring Criteria:

• Experience in acting as a QP for IMPs (experience in biological products preferred).• Knowledge of pharmaceutical development process desirable.