Quality Assurance Product Specialist – Buckinghamshire

Barrington James Europe
10 Oct 2018
15 Oct 2018
Contract Type
Full Time
Why this company:

Excellent portfolio covering Oncology / Immunology / CNS / Metabolism / Diabetes
New offices / major growth plans
Very good culture
New launches with Best in Class products coming to market
Excellent package and pension

Key Responsibilities:

Participate in the appropriate project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance.
Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations (CMOs) so that roles and responsibilities between the contracted parties are clearly defined and implemented
Ensure that an appropriate level of product batch record reviews are carried out at the CMO facilities, as necessary, prior to the release of product for sale and distribution
Regularly review non-conformances e.g. process deviations, out of specification/trend results etc at the CMO to ensure that resulting investigations have identified the root cause(s), that suitable reports have been written and that corrective and preventative actions (CAPAs) have been implemented within suitable time periods
Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO and change control processes in order to maintain GMP and regulatory compliance
Ensure that GMP stability programmes are established, implemented and regular reports issued by the CMO(s), that trends in data and confirmed out of specification results are investigated and reported, as necessary, to QA management in compliance with cGMP and regulatory requirements
For each product, maintain a Product Quality Profile, as registered with the regulatory authorities, and provide to the CMO’s Qualified Person (QP) so that product can be manufactured, controlled and released in compliance with the Marketing Authorisation
Participate in the internal audit (self inspection) programme so that any gaps and deviations identified in systems and procedures are addressed by the relevant department and corrective actions followed up within reasonable time scales.


A strong understanding of Microbiology
A broad experience of working within the pharmaceutical industry of which several years will have been operating in a QA Management position at a sterile products/biologicals manufacturing site.
Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials

This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to “Chris” at cswain@barringtonjames.com cswain (at) barringtonjames (dot) com alongside a copy of your CV.

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