Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.
We are currently 1200+ people, headquartered in the UK, with sites in Burton-on-Trent, Weybridge and the North East and global offices in the US, Australia, New Zealand, Japan, Hong Kong, South Africa, Singapore and Athens. Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.
As a member of the Quality team, this role ensures completion of day to day tasks and, as appropriate, participate in quality critical activities, with respect to GxP and Regulatory compliance.
The key responsibilities for this role are to:
- To assist in ensuring that the appropriate standards of GMP and GDP are maintained.
- Origination, review, approval, maintenance and archiving of quality documentation. This will include but not be limited to Policies, SOPs etc.
- To assist in the organisation and delivery of appropriate training
- Coordinate Quality Assurance raw data to ensure compliance with regulatory expectation.
- Collation of raw data to support monthly quality management system indicator (QMSI) reporting.
- Contribute to the delivery of QA projects.
- Deal with QA enquiries promptly with due diligence.
- Ensure all quality critical documents are appropriately drawn up, maintained, reviewed filed and archived to ensure compliance with regulatory and customer expectations. Additionally providing reports to the group head of Quality, Quality Manager and other nominated parties to show status and progress.
The successful candidate will have the following:
- Science A level/Graduate or equivalent
- Proven ability of accurate and timely completion of tasks
- Proven capability and experience of working with spreadsheets and databases
- Proven ability of providing excellent administration support to a team of people
- Proven ability of being able to prioritise and multitask.
If this role is of interest to you, please email a recent copy of your CV and a covering letter to firstname.lastname@example.org and a member of the Talent Acquisition team will be in touch.