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Qualified Person

2 months ago

Huddersfield West Yorkshire, United Kingdom SRG Full time

Title: Qualified Person (QP)

Location: Yorkshire

Employment Type: Permanent

Salary: Attractive salary depending on experience

We are currently working with a well-established pharmaceutical organisation specializing in generic pharmaceutical products, with a number of licensed medicines in the market. As the Qualified Person supporting all departments within the business, this position is responsible for guiding and advising all members of the team, contributing to the company GMP strategy and general QMS.

The main duties and responsibilities will include:

The primary responsibilities of this role involve adhering to the following guidelines and policies:

  • Orange Guide, Part 1, Chapter 2 – Personnel.
  • Orange Guide, Annex 16 – Certification by a Qualified Person and Batch Release.
  • Human Medicines Regulations (as amended), SI 2012/1916, Schedule 7, Part 3.

As well as this, daily responsibilities include:

  • Batch certification and release for licensed products manufactured on site by the company, the CMO in third countries and for medical device and cosmetic products manufactured on site by the company.
  • Approval of QP Declaration for license submissions.
  • Review and approval of Third-Party QA audit reports.

The successful Qualified Person will require prior experience within this area of work, more specifically being highly familiar with EU Directive 2001/83/EC, Article 49 and Human Medicines Regulations (as amended), SI 2012/1916, Schedule 7, Part 1.

Interested? Or know someone who will be?

SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It’s this combination that makes us different. We’re committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.