Qualified Person
A leading pharmaceutical company are looking for a Qualified Person to join their dynamic and international Quality department. They specialise in the manufacturing of solid dose drug products that are then packaged and distributed all over the world. This role is critical to the management and release of finished products form the site and requires the successful candidate to have a full understand of the GMP compliance throughout the production facility. The position is based near Oxford, UK.
The Role
You are responsible for all Quality operational activities as well as the release of products to the EU and Global market. You will also be responsible to report to the Site Quality Head on pharmaceutical affairs and issues related to QP responsibilities. This is a highly intense position and requires those who have an absolute authority on all Quality issues.
Responsibilities:
- Execute Qualified Person (QP) responsibilities, duties, batch certification and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16.
- Ensure that products are manufactured in accordance with GMP, site procedures and applicable regulatory requirements.
- Represent the company in external Quality/Regulatory inspections
- Undertake regular internal audits and self-inspections
Requirements:
- MSc in Pharmacy, Chemistry or Microbiology
- 5+ years' experience working in a pharmaceutical quality function, ideally within a development site and with knowledge of Oral solid dose drug products
- Up to date knowledge of the principles and guidelines for GMP as set out in: UK "Orange Guide", EU "Eudralex Volume 4", U.S. "CFRs" and other relevant regulations
Package:
- Salary ranging between £70,000 - £78,000
- KPI Bonus between 10-15%
- Benefits including pension, healthcare, insurances
- Relocation support if necessary
- Flexible working arrangement
