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Details

Qualified Person QP


Reference:APSG-068547 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person
Our client, a global pharmaceutical organisation are currently recruiting for a QP to join their team on a permanent basis.

Responsibilities
• Responsible for the disposition and release of product which are manufactured and/or packaged by the organisation or manufactured and/or Packaged by 3rd Party Manufacturers/Assemblers and New Product Introduction Products
• Ensure that each batch released has been produced and tested in accordance with the current EU/FDA GMP Directives and the relevant marketing authorization
o Ensure that the Marketing Authorisation and Manufacturing Authorisation requirements for the medicinal product have been met for the batch concerned, and that the principles and guidelines of GMP as stated in Directive 2001183/EC amended by 2004/27/EC and 2003/94/EC and as interpreted in the EC guide to GMP have been followed. If the product is to be released to the US market, all appropriate cGMP's should be complied with
o Ensure that the principal manufacturing and testing processes have been validated
o Ensure that all the necessary quality control checks and tests have been performed and account taken of the manufacturing and packaging conditions including a review of batch records
• Ensure that any changes or deviations in manufacturing, packaging or Quality Control have been notified in accordance with a well-defined reporting system before any product is released
• Ensure that any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate to cover changes or deviations
• Ensure all necessary manufacturing, packaging and associated documentation has been completed and endorsed by suitably authorized staff
• Complete regular audits, self-inspections and spot checks are being carried out by experienced staff
• Support the implementation of the Operational Excellence Programme on the site by encouraging staff to identify, lead and implement improvements
• To act as change agents by gaining support for and driving sustainable improvements to ways of work

Requirements
• Third level qualification in a science related discipline
• Qualified Person qualification is mandatory
• Experience in Oral Solid Dosage pharmaceutical manufacturing would be beneficial
• Audit experience would be beneficial
• Strong organizational skills with the ability to multitask and prioritise workload




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

Sinead Cullen | Tel: +353 (0) 1 507 9252