- Professional
- Office in Burton upon Trent
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.
To support growth, we are seeking a confident and proactive Quality Officer to join our Quality team based in either our Weybridge office or Burton office. This role will assist in the maintenance of the Pharmaceutical Quality System (PQS), coordinating both internally and externally with focus on client requirements, GxP and regulatory compliance.
Requirements
- Effectively perform the operational tasks within the Quality Management system, including but not limited to- Change Control, Non-Conformance, Quality Complaints, Vendor Management Records
- Create, review, and approved the applicable standard operating procedures, work instructions and forms.
- Ensure that the appropriate standards of GMP and GDP are maintained and promoted across all business divisions.
- Maintain electronic and paper records pertinent to the Clinigen Quality Assurance team.
- Support in the annual Product Quality Review process
- Support in the Batch review and release process
- Support in the management of the ongoing stability programme with the relevant Contract Manufacturing Organisations.
- Support in the review and approval of quality documentation received from Contract Manufacturing Organisations.
- Engage with internal and external stakeholders at the technical level, to assist in the investigation of issues related to quality events.
- 10. Communicate relevant aspects of the quality system to employees across business divisions, as necessary, in order to support product and service quality.
- Participate and support in internal and external audits programmes as required.
- Participate and support client or competent authority inspections as required.
- Contribute to the generation of quality, technical or regulatory reports, as required, from a quality stand point
- Assist in providing training to members of staff, across business divisions in relevant aspects of the Clinigen QMS.
- Contribute to continuous improvement exercises.
Benefits
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
