Qualified Person / Quality Assurance Manager

RBW Consulting
10 Oct 2018
14 Oct 2018
Contract Type
Full Time
Are you a qualified (EU) QP?

Have you got over 1 year batch release experience?

Are you looking for something more than just batch release?

My client is a family orientated pharmaceutical company based on the outskirts of London that are looking to expand their team and take the business to new heights. One key player in all of this is the Quality Assurance Manager position that they have open at the moment.

This opportunity is the perfect chance for a split role between QP and Quality Assurance Manager and offers a real seat at the table for anyone looking for a chance for diversity and a new challenge.

The main responsibilities for this role are:

To act as ‘Qualified Person’ in approving Finished Product for release onto the marketplace.
To act as Responsible Person as per requirements of the WDA(H) to ensure that the conditions of the licence are met and the guidelines of GDP are complied with.
To manage and supervise an adequate number of suitably qualified QC, QA and regulatory personnel and to ensure that a continuing programme of training is carried out.
To approve specifications, sampling instructions, test methods and QC procedures, including amendments.
To review and evaluate all completed manufacturing and packaging documents to ensure that each batch has been produced, tested and packed in accordance with the directives and the marketing authorisation.
To approve or reject starting materials, packaging components, intermediate bulk and finished products.
To approve and monitor suppliers of raw materials and packaging components.
To check and ensure that the QC laboratory and equipment is qualified and maintained to the required standards.
To investigate in accordance with written procedures all complaints relating to the quality of the products and if substantiated to initiate action to prevent recurrence.
To liaise with the Quality Systems Manager on all aspects of Product Change and deviations from specification and the validation required before changes can be implemented.
To liaise with Quality Systems Manager to ensure that changes to the directives are incorporated into company policy and systems.
To liaise and supervise regulatory department for variations / new manufacturing authorisations or other regulatory submissions.
To ensure that approval from the MHRA is obtained for all variations and amendments which alter either the Manufacturing or Product Licences.
To liaise with the MHRA and the Medicines Inspectorate to ensure that the Company conforms to the requirements of GMP and the Manufacturing and Product Licences.
To coordinate the preparation and hosting of MHRA and customer inspections.
To instigate and participate in “self inspections”.
To participate in external audits of contractor manufacturers and suppliers.
To refuse to sanction any action that might adversely affect the quality of any products on site and to keep the Directors informed of any problems relating to the quality of the Company’s products.
To represent quality in all site projects.

This opportunity is a great chance to improve your skill set and to develop a new level of responsibility within a dynamic and fast paced organisation based in the South East.

For the right candidate this role is offering £80,000.00 and a fantastic company benefits scheme.

If you are interested in new opportunities and looking for the a fast paced, dynamic and constantly expanding business then look no further. Apply now!

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