About Us

Rosa Quality Consulting is founded on over eighteen years of experience in quality and technical roles in the pharmaceutical and medical device industries, and was established by our Director, Lara Melchiorre.

Lara holds a BSc (Hons) in Biochemistry and began her career initially in research, before moving to the pharmaceutical liquid and solid dose manufacturing industry for Prescription Only Medicines (POM), Pharmacy (P) and General Sales List (GSL), Controlled Drugs (CD), working under Good Manufacturing Practice (GMP) systems.

With responsibilities for quality management systems (QMS) throughout her career in pharmaceutical manufacturing, Lara has a proven ability to analyse and identify issues, take responsibility for results, and is known for her skills in providing remedies that are fit for purpose, with a strong compliance history and extensive audit experience.

On moving to the pharmaceutical wholesale distribution sector for human medicines (WDA(H)), Lara became a Responsible Person (RP) and Responsible Person import (RPi), responsible for the maintenance of the authorisations of the WDA(H) and the QMS, and hosting successful MHRA inspections in line with Good Distribution Practice (GDP).

Utilising her experience gained in quality and risk management, Lara continued on to the medical device and IVD (in vitro diagnostic) industry, working to ISO 13485 and other appropriate standards and regulatory requirements to meet the obligations of the legal manufacturer.

Now providing a full time consultancy service, in addition to hands-on services and presenting at external conferences, Lara delivers strategic and operational guidance in GDP/WDA(H) and ISO 13485 QMS implementation.

Lara is a certified Lead Auditor for the Pharmaceutical Industry (PQG/IRCA) and ISO 13485 (CQI/IRCA) Medical devices – QMS – Requirements for regulatory purposes.

For advice tailored to your pharmaceutical and medical devices systems, talk to Rosa.