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Contact Info
Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
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Details

GMP Inspector


Reference:LO A008417 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Compliance Specialist

ROLE SUMMARY
Reporting to a Senior Inspector, the Inspector will be primarily responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). 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;
o Manufacturers and distributors of medicinal products.
o Manufacturers of investigational medicinal products.
o Sites involved in the storage of medicinal products.
o Manufacturers of active pharmaceutical ingredients and certain excipients.
o 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 internally and externally. The Inspector will provide support to the enforcement and execution of national regulations in relation to medicinal products. The content below represents a broad guideline for the role of Inspector. Some aspects may be subject to change in accordance with business needs.

KEY RESPONSIBILITIES

- Operational Objectives
o Preparing for and performing inspections in accordance with procedures
o Writing and compiling inspection reports when acting as lead inspector and contributing to preparation of all other inspections reports
o Reviewing inspection reports where required
o Assisting in the compilation of data and preparation of management reports as required
o Submitting reports as required and appropriate records of meetings and activities
o Maintaining a database of inspections performed o Assisting in the development and implementation of policy and practice guidelines

- Quality and Knowledge Management
o Assisting in the effective implementation of the Quality Management System within the Compliance department
o Ensuring that Inspection procedures remain up to date with relevant developments inNational, European and International regulations, legislation and guides
o Assisting to ensure that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gained by the Inspection section
o Assisting to ensure that available information and knowledge across the company is effectively used by the Inspection section

- Performance Management
o Participating in the performance development programme (PDP) within the Inspection section to maximise efficiency gains
o Working with the line manager to agree appropriate performance related targets
o Taking measures to identify and resolve issues impacting performance
o Reporting regularly on progress against specified objectives, goals and performance targets
o Effectively communicating objectives, goals and performance targets within the team o Promoting a positive, open, friendly and professional working environment

- Communication/Customer Focus
o Attending and contributing to meetings of the Compliance department as required
o Liaising with relevant departments to facilitate the identification, performance, evaluation and follow-up of inspection and compliance activities
o Participating, as required, at national and international seminars in the areas of GMP
o Representing the company, as required, at national, European and international regulatory meetings and seminars on relevant topics
o Responding to queries (technical and procedural) from internal and external customers

QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must have:
o A third level degree in a relevant scientific or related discipline
o A minimum of 3 years’ relevant work experience, in one or both of the following:
o A facility that manufactures medicinal products
o A Regulatory Authority working as an Inspector who performs GMP inspections o Knowledge of relevant European and national legislation and EU GMP guidelines
o The ability to work as part of a multi-disciplinary team o Evidence of excellent communication, report writing and decision making skills
o A proven ability to prioritise and deliver to timelines
o Valid driver’s licence and vehicle

- In addition to this the ideal candidate will have;
o A post-graduate qualification in a relevant scientific or related discipline
o Experience as a Qualified Person
o Experience in a facility that manufactures medicinal products in any of the following: quality assurance, compliance, production, technical services or validation
o Experience at a management/supervisory level
o A proven ability to work unsupervised