A contract opportunity for 6 months is available in Product Quality Pharma R&D (PQPRD) primarily based in Harlow, UK but also supporting other sites (e.g. Ware, UK.) that fall within the department’s responsibilities as directed.
This position provides an ideal development opportunity for someone to increase their quality knowledge and gain hands on experience of QA activities and GMP quality systems.
The successful candidate will have a key role in ensuring quality and compliance of Investigational Medicinal Products used worldwide in conjunction with business partners. In addition, the job holder will have the opportunity to further develop existing expertise and to gain experience within an R&D environment.
- Experience of batch release activities with respect to Manufacturing and Packaging
- Experience working in a pharmaceutical environment with knowledge of cGMP and Quality Assurance
- High level of accuracy and attention to detail
- Ability to learn quickly
- Ability to organise own work and manage/prioritise multiple tasks effectively
- Good written and verbal communication skills with the ability to convey information clearly and accurately.
- Experience of working in a team environment
- Understanding of IT applications
- Bachelor’s degree in a Scientific or Quality discipline
- Knowledge of clinical trials and investigational medicinal product supply
- Good problem-solving skills
- Documentation review including Packaging/Manufactured batch record review
- Assessment of Customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
- Assessment of Temperature excursions at clinical centres
- Highlight issues and provide assistance to business areas on quality matters.
- Communicates effectively with team members and escalates issues to the QA team