GMP Inspector - Compliance
The company is not only a fantastic place to work, but an unrivalled area within which to gain further experience.
This NCA focuses on protecting and enhancing human health through the individual contributions of each and every employee.
With a friendly, open and inviting atmosphere, this makes this already rewarding work, even more so.
Employees are provided with the means to create a great work-life balance and are consistently developed through excellent learning and development programmes
Reporting to a Senior Inspector, the Inspector will be primarily responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP).
The content below represents a broad guideline for the role of Inspector. Some aspects may be subject to change in accordance with business needs.
The role of an Inspector is to evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation (in Ireland), European Community Directives, Regulations and Guidance.
These sites may include:
- Manufacturers and distributors of medicinal products.
- Manufacturers of investigational medicinal products.
- Sites involved in the storage of medicinal products.
- Manufacturers of active pharmaceutical ingredients and certain excipients.
- Quality control laboratories.
The role involves inspecting, reporting and forming conclusions in respect of the suitability of a site for the activities which it has sought or for which it is already authorised.
The Inspector provides technical information and advice to relevant individuals and organisations both internal and external.
The Inspector provides support to the enforcement and execution of national regulations in relation to medicinal products.
- Preparing for and performing inspections in accordance with procedures.
- Writing and compiling inspection reports when acting as lead inspector and contributing to preparation of all other inspections reports.
- Assisting in the development and implementation of policy and practice guidelines.
- Maintaining a database of inspections performed.
QUALIFICATIONS AND EXPERIENCE
- A 3rd level degree in a relevant scientific or related discipline.
- A minimum of 3 year's relevant work experience, in one or both of the following:
- A facility that manufactures medicinal products.
- A Regulatory Authority working as an Inspector who performs GMP inspections.
- Knowledge of relevant European and national legislation and EU GMP guidelines.
- Valid driver's licence and vehicle.
THE NEXT STEP
If this sounds like the right role for you, please reply with an updated CV for immediate consideration.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales