You will have a varied and interesting role, providing support to all appropriate activities within the UK network and will be fully immersed in all clinical trial projects.
Your primary duties will be QP certifications and declarations, technical contribution to operations and conducting audits. You will also support on regulatory work and will be involved in a range of site Quality Assurance projects such as working on the QMS and improving facility processes and standards.
Your duties and responsibilities will include:
- Providing QP certification in compliance with regulatory requirements and if required, specific client technical agreements
- Providing QP GMP declarations, including on site audits if required, in support of importation activities.
- Provision of GMP training.
- To provide information and training on the QP roles and responsibilities to company personnel.
- 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 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.
- Occasional travel as required.
The experience, qualifications & abilities we are looking for
- You must be an eligible Qualified Person (as per Article 49 of Directive 2001/83/EC) - we are open to someone who is newly qualified or more experienced
- Biological experience or education - advantageous, not essential
- Open to occasional national and international travel - preferred, not essential
- Knowledge of the pharmaceutical product development process - desirable, not essential