Description
Qualified Person required for a leading medical solutions company to act as an appointed Quality Controller with responsibility across the Amersham Pharmaceutical Manufacturing Operation to provide advice and Quality Assurance input on pharmaceutical and GMP issues.
The Qualified Person will be responsible for supporting the Quality Assurance audit function to ensure GMP compliance both within the company and at key suppliers; accompany and coordinate regulatory inspections from external bodies; review batch manufacturing records and the process of manufacture supporting the decision to release product in compliance with all license and GMP requirements; operate to a code of conduct defined by the joint professional bodies; represent QA on a range of development projects and advise on the adequacy of validation of facilities, equipment and new products/processes, including designing strategies to ensure adequate data is gathered; contribute to the development of policy within the QA organisation; actively participate in accident & incident investigation and follow up; coordinate Product Corrective Action activities and liaise with the regulatory agencies as appropriate in these circumstances.
Qualification & Skill Requirements:
- Eligible for Qualified Person status on UK product licenses under Directive /EC
- Degree in relevant science subject from a recognised University or equivalent
- Experience in a relevant field in the pharmaceutical industry
- Member of the relevant professional body eg RPSGB
- Experience of inspections from regulatory agencies eg FDA and MHRA
- Computer literate eg Word, Outlook, Excel, PowerPoint
- Excellent verbal and written communication skills
Please apply through this advert of alternatively call Stef Walters.