Qualified Person
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Job Summary
To be responsible for QP certifications and declarations technical contribution to the operations of Fisher Clinical Services Horsham oversight of the sites GMP/GDP compliance and conducting audits.
To provide support to all appropriate and relevant activities within FCS Horsham to assure the quality and safety of medicines. Achieved through a detailed understanding of pharmaceutical law and administration Pharmaceutical Quality Systems and Good Manufacturing Practice.
To be legally responsible for certifying batches of medicinal products before they are used in clinical trials or made available on the market.
Duties and Responsibilities
- Provide QP certification of lMPs and commercial medicinal products in compliance with regulatory requirements and if required specific client technical agreements.
- Provide QP GMP declarations including on site audits if required in support of importation and certification activities.
- Conduct/support internal and external audits as required.
- Review and final approval of packaging batch records
- Have oversight of support maintain and improve the sites GMP/GDP compliance and Pharmaceutical Quality System
- Provide final disposition of batches manufactured at and imported into the Horsham site
- Ensure up to date awareness of the regulatory issues and changes continued professional development and maintenance of an appropriate CPD record
- Support the client service teams to enable close collaboration with customers regarding UK and/or EU requirements for QP certification
Education/Qualifications
- Essential: Meets the requirements for Qualified Person status as defined by the MHRA (regulation 41 and schedule 7 of the Human Medicines Regulation 2012 as amended)
Experience
- Desirable: Experience in acting as a QP for IMPs and/or ATIMPs
- Desirable: Knowledge of the pharmaceutical development process desirable
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Key Skills
- Accounts Management
- Facilities Management
- Law Enforcement
- Administration Support
- ERP
- Development
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
