Quality Operations Specialist
Location Abingdon, Oxfordshire
CY Partners are working with a pharmaceutical services provider, based in Abingdon, to help recruit a Quality Operations Specialist.
Reporting to the Quality Operations Manager, the successful candidate will provide support to API Production, API Chemistry, QC, Warehouse and Engineering.
Key responsibilities include but are not limited to:
- Provide Quality oversight activities across the site including the assurance of facility, equipment calibration and maintenance, and provide technical GMP support to the other departments and Clients as required
- Identify issues and participate in the investigation of problems to identify root causes associated with deviations and OOS investigations
- Work with other departments to find resolutions to any non-conformances identified
- Aid in the identification of inefficient processes and introduction of lean alternatives whilst maintaining compliance
- Responsible for decisions related to GMP compliance in relation to the work and provide advice to other departments to ensure their compliance to company policies, best practice and cGMP
- Prepare product quality reviews (PQRs)
- Review of manufacturing batch records, cleaning documentation and associated analytical data
- Raw material code assignment and risk assessments
The ideal candidate will have the following skills / experience:
- BSc or higher in a scientific area
- Quality Assurance experience in a GMP environment
- Good knowledge of other regulatory requirements (ICH, EU, CFR)
- Root cause analysis training and experience preferred
If you meet the above requirements and would like to find out more about this opportunity, contact Charlotte on 07851246841.