Qualified Person

At Argenta, we’re more than a company - we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.

Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions cover every stage of the process, from molecule to market.

We are in a unique position: the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated solely to animal health.

We are ambitious, growing, and building a One Team culture, grounded in our values: 

We are team players.

We are doers.

We are customer-centric.

We are innovators.

As a global company, we value diversity and the richness it brings - across locations, career stages, backgrounds, and experiences. When every person brings their best “paw” forward, we make animals' lives better.

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.

Team players who want to do great work and find innovative ways to make animals’ lives better through our customer-centric efforts should apply.

About the Role

An amazing opportunity has arisen for a Qualified Person (QP), within our Dundee manufacturing site.  The QP will Act in accordance with requirements for Qualified Persons, set by the Veterinary Medicines Regulations/statutory instrument 2013-2033.  And to be named on the site licence as QP, ensuring all products certified meet their intended expectations for quality, safety and efficacy.

To certify each batch of finished product ensuring that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation, the principles and guidelines of EU Good Manufacturing Practice or the good manufacturing practice of a third country recognised as equivalent under a mutual recognition agreement and any other relevant legal requirement before it is placed on the market. And to support oversight of the QMS to ensure it complies with all legislative requirements outlined in the VMR and Eudralex volume 4.

Key Accountabilities:

Before certifying a batch prior to release the QP doing so should ensure, with reference to the guidance above, that at least the following requirements have been met and compliance with Annex 16 is met prior to certification:

the batch and its manufacture comply with the provisions of the marketing authorisation (including the authorisation required for importation where relevant);

manufacture has been carried out in accordance with Good Manufacturing Practice or, in the case of a batch imported from a third country, in accordance with good manufacturing practice standards at least equivalent to EU GMP;

the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records;

any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority;

Notifying site leadership team and client in the event that the QP becomes aware of an issue which may impact batch compliance with registration;

all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes;

all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so;

all audits have been carried out as required by the quality assurance system;

the QP should in addition consider any other factors of which their aware which are relevant to the quality of the batch;

A QP should maintain their knowledge and experience are up to date in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify.

If a QP is called upon to certify a batch of a product type with which he is unfamiliar, for example because the manufacturer for whom he works introduces a new product range, they should first ensure that they have gained the relevant knowledge and experience necessary to fulfil this duty. In accordance with national requirements the QP may be required to notify the authorities of such a change and may be subject to renewed authorisation.

Perform duties in compliance with the “Qualified Persons in the Pharmaceutical Industry Code of Practice”

In addition to the standard responsibilities of a Q.P. defined above this position has the following responsibilities

To co-ordinate QP release activities across the QP team ensuring site QP activities support the planned production and dispatch schedules

Act as Primary Deputy for the Site Quality Manager when required

Perform audits of external companies where required

Provide support and guidance on quality issues

Comply with all company local and global policies

Liase with clients

Perform any other duties or serve in such other capacity as may be determined by Company management

Qualifications:

Degree in appropriate scientific discipline outline in the VMR; or where appropriate, chartered status with one of the below royal societies

Member of the Royal Society of Chemistry, Biology of Pharmacy

Certificate of Eligibility to act under permanent provisions as a qualified Person

Preferably qualified as a lead auditor (PR325/PR330)

Knowledge/Experience:

To have acted as a QP, named on a license for at least 3-5 years. Preferable experience working with Veterinary medicinal products, and non-sterile suspensions and liquids