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 800+ people, headquartered in the UK, with global offices in the US, Australia, New Zealand, Japan, South Africa, Singapore, Hong Kong 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 highly motivated, ambitious and committed individuals to join our highly successful team.
The Quality Assurance Specialist is responsible for assisting the Quality Assurance Team, providing administrative, technical and quality support to the business in relation to Quality Assurance related matters, ensuring regulatory compliance and to investigate quality issues.
The role is responsible for:
- To help ensure that the provisions of the company’s licences are observed
- To help ensure that the operations do not compromise the quality of medicines
- Maintain the Clinigen paper and electronic filing system regulatory and quality documentation
- To deal with both internal/external customers and suppliers at a technical level to investigate issues related to quality problems and customer complaints, which may be both sensitive and complex (including complaints, deviations and CAPA’s
- To assist the Head of Quality in providing training to members of staff on relevant components of Quality Management
- Conduct audits of key external bodies, according to the Clinigen Group external audit plan. This includes report writing, follow-up and close-out of audit observations
- Conducting internal audits, according to the Clinigen Group internal audit plan. This includes report writing, follow-up and close-out of audit observations
- Participation in Client Hosted Audits and Competent Authority Inspections, where requested by the Head of Quality
The successful candidate will have the following:
- Demonstrable experience within a quality assurance role, or related (essential)
- Life Sciences Graduate, Pharmacist or Chemist;
- Excellent attention to detail;
- Demonstrable business and commercial awareness;
- Experience of working independently and as part of a team;
If this role is of interest to you please send a recent copy of your CV to firstname.lastname@example.org and a member of the Talent Acquisition team will be in touch.