The Clinigen Group is a rapidly-growing specialty pharmaceutical and services company, with one clear aim: to deliver the right drug to the right patient at the right time. To achieve our aim, we have built a group of complementary businesses which operate efficiently in a complex global regulatory environment and which can ensure that precious medicines are delivered securely and effectively, wherever they are needed. In April 2015, Clinigen acquired Idis, the market leader in the global supply of unlicensed medicines and the Group now operates as four synergistic businesses: Clinigen Specialty Pharmaceuticals, Clinigen Clinical Trial Services, Idis Managed Access (this now includes the previously branded Clinigen GAP business) and Idis General Access. Headquartered in the UK and with offices in the US and Japan, Clinigen has the ability and capability to acquire, license and revitalise niche, hospital-only critical care medicine and to source and supply our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials. Clinigen has seen six-fold revenue growth over the past four years and our work has been recognised in being recently named the winner of the Business of the Year Award with Turnover of €26-150m at the 2014/15 European Business Awards.
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 email@example.com and a member of the Resourcing team will be in touch.