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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

GMP Inspector


Reference:SCAQKI-440863 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

GMP Inspector
Reporting to a GMP Inspection Manager, the GMP Inspector will be responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The Manufacturing Compliance Specialist will evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation 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.
• Contract quality control laboratories.

Responsibilities
• 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.
• Provides support for the co-ordination of recalls of all associated regulated products from the marketplace.
• Provide technical information and advice to relevant individuals and organisations both internal and external to organisation.
• Provide support to the enforcement and execution of national regulations in relation to medicinal products.
• Organising and carrying out inspections in accordance with the organisation procedures
• Write inspection reports when acting as lead inspector and contribute to preparation of reports for joint or accompanied inspections
• Assist in the compilation of data and preparation of management reports as required.
• Apply risk management principles
• Submit reports as required and maintain appropriate records of meetings and activities
• Maintain the database of inspections performed
• Assist in the development and implement of policy and practice guidelines
• Provide support to other areas of the organisation where appropriate

Requirements
• A third level degree in a relevant scientific or related discipline
• A minimum of 3 years’ relevant work experience, in either a facility that manufactures medicinal products or a Regulatory Authority working as an Inspector who performs GMP inspections
•Knowledge of relevant European and national legislation and EU GMP guidelines
• Have worked as a Qualified Person
• Experience in a facility that manufactures medicinal products in any of the following: quality assurance, compliance, production, technical services or validation
• Have worked as a Qualified Person
• A full clean driving licence and car

If you would like further Information you can contact the recruiter directly:

For more information contact Sinéad Cullen on +353879500821 or [email protected]