Job Description

CHR Life Sciences are pleased to be working in partnership with a UK based pharmaceutical business, who are seeking a Qualified Person.

Responsibilities include:

• In your role as a Qualified Person, you will drive the transformational quality culture initiatives across the site, define GxP practices and standards for the site, and lead gap assessments and improvement projects as required.
• You will provide quality leadership to cross-functional teams working on FMEA, root cause analysis, and other investigative tools.
• As a QP you will escalate to the Head of Quality and SLT any trends and quality issues that are detected during batch review.
• You will provide leadership during agency inspections, perform QP batch certification and participate in internal and external audits.

The Successful candidate will:

• Be eligible to perform the duties of a Qualified Person under the provisions of Directive 2001/83/EC, Directive 2001/82/EC, Directive 2001/20/EC, and Statutory Instruments (SI) 2012 1916, SI 2004 1031 and SI 2013 2033.
• Have extensive experience in pharmaceutical quality departments.
• Possess in-depth knowledge of licensed products, processes, and legislation.
• Have previous experience working with MHRA / VMD, FDA and participating in regulatory agency inspections.

QP | Qualified Person | GxP | Quality | Internal Audits | External Audits | Audits | MHRA | Regulatory Affairs | Release | Batch | Quality Assurance