Job Description

Job Description - Qualified Person

CHR Life Sciences are pleased to be working in partnership with a pharmaceutical company based in the Midlands, who are actively seeking a Qualified Person to join their Site Leadership Team. As the Qualified Person, you will be tasked with batch release activities. You will also work with the wider Quality Assurance team to implement Quality improvements and help drive a Quality first culture.

Responsibilities include:

Undertake the duties of a Qualified Person as defined in SI 2012-1916 and Directive 2001/83/EC

Working closely with the site leadership to help advise on Quality issues and liaise with regulatory agencies.

As the Qualified Person, you will act as a point of contact for customers, giving exposure to the Quality standards.

You will help facilitate site wide GMP compliance. This will include managing and developing Quality Systems, including CAPA, OOS, Deviations, Change Controls and Root Cause Analyses.

The Successful candidate will:

Be certified as a Qualified Person, as per Directive 2001/83/EC.

Thorough knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products.

Experience in pharmaceutical manufacturing of solid dosage forms.

QP | Qualified Person | Quality Assurance | QA | CAPA | QMS | Quality Systems | Audit | Documentation | Batch | SOP | Batch | Release