Interim Qualified Person / Responsible Person

Sector: Pharma

Current Salary Range: 1,200 per day

Location  Hampshire

About the Candidate

A Professional Quality Manager with broad experience and a proven track record in pharmaceutical GMP gained in quality-orientated roles in both commercial manufacture, drug development & distribution within blue-chip pharmaceutical companies. Over 20 years’ experience as an IMP Qualified Person (QP), under the clinical trials directive, releasing investigational medicinal products (IMPs). Also eligible under the permanent QP provisions, as per directive 2001/83/EC, to release commercial products. Experience working as an RP/RPi on various WDAs and performing QP Oversight for IMPs imported into the UK.

What Makes them great?

Eligible as a Qualified Person for the release of Investigational Medical Products (IMPs) under the clinical trials directive 2001/20 EC and commercial products under directive 2001/83/EC.
In-depth knowledge of the role of the Responsible Person and performed the role of RP/RPi under company WDAs.
In-depth manufacturing knowledge of solid dosage forms, metered dose inhalers, oral liquids and sterile manufacturing processes including radiopharmaceuticals.
Internal and external auditing, including third party manufacturers (ISO 9000 lead auditor trained)
Proven quality management system support including complaints management, technical agreements, SOP approval, change control, deviation and Vendor & CAPA management.

Their Experience

Qualified Person, responsible person

Other Details