It's a legal requirement for every manufacturer of pharmaceutical products to have a Qualified Person.
Assuring the quality of medicines requires a thorough understanding of pharmaceutical law and administration, Pharmaceutical Quality Systems (PQS) and Good Manufacturing Practice (GMP). Pharmaceutical manufacturing supply chains are global and an increasingly complex landscape which the QP must be able to skilfully navigate to uphold patient safety.
QPs use their analytical skills to investigate problems in the manufacturing and analysis of medicines. Strength of character is important – a QP must remain unflappable under pressure and demonstrate strong leadership skills when guiding cross-functional teams.
Most QPs are employed in the pharmaceutical industry, but some are employed or contracted to work at licensed NHS (or equivalent) manufacturing sites.
Eligibility for QP status is administered by the Joint Professional Bodies (JPB): the Royal Society of Chemistry, Royal Society of Biology, and Royal Pharmaceutical Society. We do this on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), and the Veterinary Medicines Directorate (VMD).
Further information on the Qualified Person and the RSC’s requirements for their role, can be found here.
Here is a register of our members who are eligible to act as Qualified Persons.