Report this ad

The company is a Quality Assurance Service provider company who partner with Cell and Gene Therapy, Pharmacuetical and Biotech companies across Europe.

The position involves planning, organizing and reporting on internal and external Good Manufacturing Practice (GMP) audits to support the audit schedule. Providing GMP support to a variety of international clients is also required. The role will report to the Quality Assurance Manager.

Key responsibilities include:

* Planning and scheduling of Good Practice audits as requested by clients

* Completing audits by visiting relevant sites, interviewing staff and reviewing documentation per applicable regulations

* Categorizing and classifying audit observations, formally reporting these and proposing corrective and preventative actions

* Reviewing proposed corrective actions and action plans from auditees

* Performing follow up activities as needed

* Conducting batch record reviews

* Performing trend analyses on completed audits

* Liaising with department heads to support business improvement initiatives

* Carrying out internal and vendor audits

* Leading or participating in internal/external projects such as gap analyses, quality management system developments, training, and quality assurance support

* Maintaining internal quality systems

* Assisting in hosting client audits

The successful candidate will have a science degree or equivalent, along with prior GMP auditing/GMP support experience (minimum 3-4 years) in a pharmaceutical or clinical trial setting. Excellent knowledge of compliance requirements for clinical trials is essential, as well as a strong understanding of the clinical process. A full driving license and willingness to travel is necessary

Benefits: pension scheme, private healthcare