I am working with a global, rapid-growth Pharmaceutical company based in Buckinghamshire who are looking to take on a Quality Assurance Product Specialist.
As QA Product Specialist, your main purpose will be to provide QA support for the manufacture of commercialised products. To ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements.
The main responsibility will be to write/ review all GMP and technical documents and ensure compliance with EU and US requirement.
- A Life Science degree or equivalent preferable in microbiology.
- A broad experience of working within the pharmaceutical industry of which several years will have been operating in a QA Management position at a sterile products/biologicals manufacturing site.
- Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
- Sound knowledge of QC and Stability chemical analytical testing techniques for Sterile/ biologics
- Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems
- Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines
If this is of interest to you, please get in touch as soon as possible!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales