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 site's 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 site's 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