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Qualified Person

4 weeks ago

Huddersfield, Kirklees, United Kingdom SRG Full time
Job Title: Qualified Person

We are seeking a highly experienced Qualified Person to join our team at SRG, a leading recruitment company specializing in the science, engineering, and pharmaceutical sectors.

Job Summary:

The Qualified Person will be responsible for guiding and advising all members of the team, contributing to the company GMP strategy and general QMS. This role involves 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.

Key Responsibilities:

The primary responsibilities of this role 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.

Requirements:

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.

About SRG:

SRG is the UK number 1 recruitment company specializing 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.