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.
• 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
• Degree in pharmacy or other relevant life science disciplines
• Minimum of three years relevant experience working in a facility licensed to manufacture biotech and/or sterile medicinal products, in any of the following areas: quality assurance, compliance, quality control, production, technical services or validation, ideally incorporating experience at a management/supervisory level.
• A full clean driving licence and car
• Experience in the manufacture of biotech medicines, non-sterile medicinal products, sterile medicinal products
• Have worked as a Qualified Person
• Quality System / GMP Auditing
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252