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The Qualified Person will provide support to all appropriate and relevant activities within Fisher BioServices, Bishops Stortford.
The role has three primary functions, QP certifications and declarations, technical contribution to the operations at FBS Bishops Stortford 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 with a strong GMP emphasis.
The jobholder will interface with the Fisher Clinical Services, Horsham ‘QP team’, supporting the QP certification activities, maintaining an up to date awareness of current legislation and contributing to QP policies.
- To provide QP certification in compliance with regulatory requirements (EU GMP Annex 16) and if required, specific client technical agreements.
- To provide QP GMP declarations including on site audits if required, in support of importation activities.
- Conducting internal and external audits as required
- To act as the Quality Lead, the primary contact point for Quality for major clients.
- Provision of GMP training.
- To provide information and training on the EU QP roles and responsibilities to FBS personnel in the UK and outside the UK.
- Provide support to Business Development/ Sales and Project Management at pre-contract stage to assess new contracts.
- To maintain an up to date awareness of 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 audits with QP input.
- Meets the EU requirements for Qualified Person status
- Experience in acting as a QP for IMPs
- Knowledge of pharmaceutical development and manufacturing process
- Knowledge of Biological substances
Thermo Fisher Scientific is an Equal Opportunities Employer and does not discriminate on the basis of race, colour, religion, sexual orientation, gender identity, national origin, disability or any other legally protected status.
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