Qualified Person

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About Argenta: a global team dedicated to healthier animals, supporting companies to develop and manufacture health products for pets and livestock. We are the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated solely to animal health.

We value a One Team culture and a diverse workforce across locations, career stages, backgrounds, and experiences. Our bases are in New Zealand, the US, the UK, and Europe, with 900+ colleagues.

With opportunities to apply your skills in a customer-centric and innovative environment, Argenta invites qualified professionals to join our Dundee manufacturing site as a Qualified Person (QP).

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 instruments. The QP will be named on the site licence as QP, ensuring all products certified meet their intended quality, safety and efficacy.

Key responsibilities include certifying each batch of finished product to confirm manufacture and testing comply with the marketing authorisation and EU GMP standards (or equivalent third-country GMP) and supporting oversight of the QMS to ensure compliance with the VMR and Eudralex Volume 4.

• Before certifying a batch prior to release, ensure, with reference to the guidance above and Annex 16, that the following requirements are met and compliance is demonstrated:
• The batch and its manufacture comply with the marketing authorisation.
• Manufacture has been carried out in accordance with Good Manufacturing Practice or, for a batch imported from a third country, GMP standards at least equivalent to EU GMP.
• The principal manufacturing and testing processes have been validated; consider actual production conditions and manufacturing records.
• Any deviations or planned changes in production or quality control have been authorised; changes requiring variation to the MA or manufacturing authorisation have been notified to and authorised by the relevant authority.
• Notifying site leadership and client if the QP becomes aware of an issue that may impact batch compliance.
• All necessary checks and tests have been performed, including any additional sampling or tests due to deviations or planned changes.
• All necessary production and quality control documentation has been completed and endorsed by authorised staff.
• All audits have been carried out as required by the quality assurance system.
• The QP should consider other factors relevant to batch quality and maintain up-to-date knowledge and experience in quality management and technical progress.
• If certifying a batch of a product type with which the QP is unfamiliar, ensure necessary knowledge and experience are gained; national requirements may require notifying authorities of changes and renewed authorisation.
• Perform duties in compliance with the Qualified Persons in the Pharmaceutical Industry Code of Practice
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• In addition to standard responsibilities, coordinate QP release activities across the QP team to support planned production and dispatch schedules.
• Act as Primary Deputy for the Site Quality Manager when required.
• Perform audits of external companies as needed.
• Provide support and guidance on quality issues.
• Comply with all local and global company policies.
• Liaise with clients and perform other duties as determined by Company management.

• Degree in an appropriate scientific discipline as outlined in the VMR; or chartered status with one of the Royal Societies (e.g., 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).

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

• Mid-Senior level

• Other

• Other

• Pharmaceutical Manufacturing

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