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GMP Inspector

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
15 Sep 2022
Closing date
15 Oct 2022

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Discipline
Quality, Regulatory Affairs, Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

GMP Inspector, Inspection – Compliance

On behalf of our client, we are currently recruiting for a GMP Inspector. This is a 3 year contract role. The role involves approx 80 days travel per year, predominately Ireland but occasionally abroad. A full driving licence and vehicle is essential.

 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; 

  •   Manufacturers and distributors of medicinal products.
  • Manufacturers of investigational medicinal products.
  • Sites involved in the importation and / or storage of medicinal products. 
  • Manufacturers of active pharmaceutical ingredients and certain excipients.
  • Quality control laboratories.
  • Office based sites involved in batch certification activities only.

 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 will provide support to the enforcement and execution of national regulations in relation to medicinal products. 

QUALIFICATIONS AND EXPERIENCE

  •  To be considered for this post, candidates must have:

o A third level degree in a relevant scientific discipline

o A minimum of 3 years relevant work experience, in at least one of the following:  

  • Experience in a facility that manufactures biological active substances or finished medicinal products in any of the following functions: quality assurance, compliance, production, technical services or validation
  • Experience in a Regulatory Authority evaluating manufacturing processes generally

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 A valid driver’s licence and vehicle

  • In addition to this the ideal candidate will have;

o Experience in biological / sterile product manufacture and / or microbiology

o A post-graduate qualification in a relevant scientific or related discipline

o Experience as a Qualified Person 

o Experience at a management/supervisory level

o A proven ability to work unsupervised  

 Availability to travel for national and international inspections is a requirement in this role.

 For full details contact Linda at +353 1 2784703 or email your CV to ldunne@thornshaw.com. Thornshaw Scientific is a division of the CPL Group 

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
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