Staff QA Engineer
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Job Location:
Hertfordshire - UK
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Required Experience:
Staff IC
Key Skills
- Corporate Communications
- Apache Commons
- Community Support
- Jira
- Java
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
