Quality Assurance Product Specialist
- Clinical Research
Quality Assurance Product Specialist (Trainee) – Fluent Japanese
Competitive starting salary and benefits package
We are looking for a Graduate Quality Assurance Product Specialist to provide QA support to the manufacture of products commercialised within any of our Clients group of companies. 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.
You will write/ interpret / translate / review key GMP and technical documents and ensure compliance with EU and US GxP requirements.
- A Life Science degree or equivalent preferably in biochemical process technology or advanced biochemical /chemical analytics.
- Fluent in the technical aspects of both the English (written & spoken) and the Japanese (written and spoken) languages is key to this role.
- Some experience or understanding of the requirements of working within the pharmaceutical industry, specifically within a quality management position at a sterile products/biologicals manufacturing site.
- Solid basic 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 Steriles / 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 you meet the outlined requirements and are interested in this position, then please feel free to send your CV to email@example.com or if you have any questions regarding the role then please call 0118 959 4990.