Qualified Person Pharmaceutical Manufacturing

GLOBAL PHARMACEUTICAL HAS AN IMMEDIATE REQUIREMENT FOR A QUALIFIED PERSON. YOU WILL BE RESPONSIBLE FOR ENSURING THAT ALL PRODUCTS HAVE BEEN MANUFACTURED WITHIN THE PROVISIONS OF THE EU MARKETING AND MANUFACTURING AUTHORISATIONS AND IN ACCORDANCE WITH CGMP REQUIREMENTS BEFORE CERTIFYING THEIR SUITABILITY FOR DESPATCH TO MARKET.

In taking this decision the QP takes responsibility for ensuring that the products are of adequate quality, safety and efficacy for its intended use and presents no risk to patients.

You will carry out your duties in line with the Code of Practice for Qualified Persons in the Pharmaceutical Industry. This includes performing batch certification for sale and despatch to market for product lots manufactured by the onsite operation team or by approved Third Party Operations in accordance with regulatory requirements.

In addition you will ensure that the Notification to Management process is effective at all levels and functions to ensure appropriate communication and resolution of quality issues. You will also ensure that all principal manufacturing, packaging and testing processes have been appropriately validated and that a continuous revalidation programme is in place.

You will represent the Quality Organisation on key site quality review and decision making forums and make appropriate recommendations to the QA Team Leader and Site Head of Quality if required for further action on significant quality issues. Ensure final outcomes are implemented.

Development, approval and implementation of standards, procedures and systems and ensure delivery of audits and inspections carried out as required within the Quality Management System. These audits, self-inspections and spot checks are carried out by experienced staff.

You will also review Annual Product Reports and continuously monitor key site metrics and trends including, stability data and complaint investigations ensuring any immediate or necessary corrective actions are implemented.

TO BE SUCCESSFUL YOU WILL BE A QUALIFIED PERSON WITH PREVIOUS EXPERIENCE AS A QUALIFIED PERSON WITHIN A PHARMACEUTICAL MANUFACTURING ENVIRONMENT. YOU WILL ALSO HAVE THE LEADERSHIP AND MANAGEMENT SKILLS WHICH ALLOW YOU TO COACH, MENTOR AND ADVISE QUALITY ASSURANCE REPRESENTATIVES, MANUFACTURING TEAMS AND ANY OTHER PERSONS INVOLVED IN ANY ASPECT OF THE QUALITY MANAGEMENT SYSTEM.

YOU WILL BE RESULTS FOCUSED, HAVE A GREAT ATTENTION TO DETAIL, HAVE STRONG ANALYTICAL SKILLS AND BE DRIVEN TO IMPLEMENT A CONTINUOUS QUALITY IMPROVEMENTS CULTURE.