Qualified Person (QP)

Mentholatum – Qualified Person

With a diverse brand portfolio including the world-renowned topical heat and freeze brands, Deep Heat & Deep Freeze, The Mentholatum Company has an enviable 135-year history as a global specialist in Family Healthcare.

Brightwork are delighted to be working on behalf of Mentholatum to recruit a Qualified Person who will be responsible for certifying the suitability for release of medicinal products and ensuring they have been manufactured and produced in a manner that ensures their quality, safety and efficacy.

The role – Qualified Person

You will have a pivotal role in ensuring batch certification of Human Medicinal products prior to release for market sale, maintaining patient safety, product quality and product efficacy.

Your principal duties and responsibilities will include;

• Execution of all QP operational activities to meet all legal and regulatory requirements as described in 2001/83/EC and Eudralex Volume 4 Annex 16
• Support QA Leadership in the day-to-day management of the Pharmaceutical Quality System (PQS) to ensure compliant life cycle management of products
• Provide support and Guidance on Quality matters across the business as appropriate to ensure QA drives continuous improvements and maintains fit for purpose product development and management
• Manage the release of medicines to an average target time of 14 days from MUK
• Identify any issues / problems within batches and identify and implement associated solutions with all relevant stakeholder groups
• Manage the batch release process including management of Locum QPs, organising release of product and other activities as required to maintain the manufacturing authorisation with the MHRA
• Proactively support all internal and external stakeholder groups and provide timely responses to queries and communications
• Participate in audits/investigations as QP
• Undertake a critical role in upholding the highest standards of product quality, safety, and efficacy
• If eligible, perform EU QP duties for release of medicinal products to EU from Mentholatum’s Irish entity, based at Dublin airport

You will be a Qualified Person, on a UK licence, with responsibility for ensuring that all products are manufactured and released in compliance with EU directive 2001/83/EC. You will have a wealth of experience undertaking a companywide, multiple site Qualified Person role and will be responsible for ensuring product development, manufacturing and batch release meets all industry, company, client and regulatory requirements. A commercially aware and pragmatic individual who has a track record of working collaboratively with the business to enable growth, you will possess highly effective communication skills and be well versed working with multiple internal, external and regulatory stakeholder groups.

Based from the site in East Kilbride, this is an excellent opportunity within a highly innovative organisation dedicated to providing a first-class working environment and may be offered on a flexible / hybrid working basis in conjunction with affording a highly competitive remuneration package.

For an informal discussion or more details on this outstanding opportunity, please call Ian Grant on or email ian.grant@brightwork.co.uk.