Qualified Person

Information

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Location: Dublin

Type: Permanent

Salary: Negotiable

Contact: mtreacy@asset.ie

Reference: QP

Updated: 17/08/2018 16:39:48


Job Description

JOB PURPOSE

The Qualified Person is responsible for supporting Quality Systems and ensuring GMP compliance across the site.

KEY TASKS AND RESPONSIBILITIES

Responsible for the disposition and release of product.
Manufactured and/or packaged (inclusive of Investigational Medicinal Products (IMPs)) manufactured at our Client's site or by 3rd Party Manufacturers.
New Product Introduction Products.
Ensure that each batch released has been produced and tested in accordance with the current EU GMP Directives and the relevant marketing authorization.
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.
Ensure that the principal manufacturing and testing processes have been validated.
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.
Ensure regular audits, self inspections and spot checks are being carried out by experienced staff.
Take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting batch release of products manufactured by our Client and their subcontractors.
To act as change agents by gaining support for and driving sustainable improvements to ways of work.

SKILLS, EXPERIENCE AND QUALIFICATIONS

A Bachelor's degree in a Science related discipline.
Knowledge of EU quality-related pharmaceutical regulations.
Qualified Person qualification is mandatory.
Experience in Oral Solid Dosage pharmaceutical manufacturing would be beneficial.
Strong organizational skills with the ability to multitask and prioritise workload
The ability to be self-driven and capable of working on own initiative.


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