Description
A requirement is needed to perform the review of the PQRs of all the UK marketed products against the relevant MA according to the requirements of the Orange Guide and using the SOP provided. They are also responsible to highlight missing PQR's or deficiencies in those reviewed to the responsible QP.
* Develop and maintain a spreadsheet of those PQR's to be reviewed and track progress against this.
* Document the results of the review and any gaps found and pass this to the QP for approval.
* Liaise with responsible sites over missing PQR's.
Ideal Background (State the preferred education and experience level)
Education (minimum/desirable): Life Sciences Degree or equivalent experience (2 - 3 years) Languages: English
Experience: Pharmaceutical Quality Assurance or regulatory/GMP background.
hy-phen Limited is acting as an Employment Business in relation to this vacancy.