Head of Operational Quality and Formulation

Location: North-EastSRG is working with a leading sterile pharmaceutical company who has become a leader in specials with an ever-expanding footprint, supplying hard-to-source product to patients who need them.They are now looking for a Head of Operational Quality and Formulation to be based at their site in the North-East Near Newcastle and oversee the formulation and Safe and timely release of life saving products.The Role:

As the Head of Operational Quality and Formulation you will be overseeing the Quality, Formulation and Production teams ensuring GMP and regulatory compliance of manufactured specials products, making sure they are released for the patients who need them.Key responsibilities:

Act as the Quality Controller for the Manufacturers Specials Licence.Establish, review and monitor Key quality metrics and drive continuous improvement.Oversee new product introduction, assessing feasibility and guiding new formulations to production readiness.Design and oversee stability programs, pharmacovigilance systems and ensure compliance with GMP, GDP and MHRA.Lead investigations of deviations, complaints and root causes, implementing CAPAs.Required:

A degree or higher qualification/ equivalent experience in relevant scientific field.GPhC registration is essential.Proven experience in a pharmaceutical formulation, QA or manufacturing with a strong knowledge of GMP, GDP and MHRA Specials guidance.Strong management and project coordination skills.Carbon60, Lorien and SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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