Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
This is a Fixed Term Contract (2 years) and is part-time (22.5 hours per week, Monday-Wednesday)
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.
Travel 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.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
