QA Manager/QP

North Wales
£60000 - £70000 per annum + negotiable, plus benefits
04 Jun 2014
02 Jul 2014
RE-12524940
Jade Tetlow
Healthcare
Permanent
Full Time

The organisation develops and manufactures a wide range of healthcare products which are sold in more than seventy five countries world wide.

Due to the size of the company, the role will give you exposure to other areas of the business, giving you experience that you will not have in large Pharma. As they are part of a group, there will be opportunity for future personal development.

Responsibilities may include:

  • Acting as Qualified Person (Primary) as per directive 2001/83/EC
  • Provide QA support for EU importation of pharmaceutical products, and batch release for the EU Market.
  • Hosting both Regulatory and Customer Audits with 100% involvement and participation.
  • Manage/maintain the Site Master File & Site License
  • Ensure that existing and new equipment, facilities and processes, are validated/calibrated on a regular basis
  • Schedule and lead routine vendor audits and vendor qualification audits
  • Run GMP training courses for new starters and refresher courses for all staff on an annual basis

Experience

  • Bachelor's degree in chemistry, biology, microbiology or a related discipline.
  • Experience in Quality Assurance, Quality Control, Compliance and/or Manufacturing.
  • Qualified Person (2001/83/EC)

Salary is £60-70k plus benefits however this could be negotiated for the right candidate.

Please send an updated CV to Jade Tetlow or call 0207 758 7311 if you have the relevant experience required for this role.