Stability & Support Coordinator – £15.88ph
Our client, a global pharmaceutical company based in Speke, is looking to recruit a Stability Support Coordinator to join their busy and lively team on a temporary basis for 4 months, possibly longer.
As a Stability Support Coordinator, you will be expected to effectively coordinate and support the site stability programme, site and stability aseptic sampling activities and QC sample management of receipt and delivery of 3rd party samples and sample retains in compliance with ICH, WHO, the company quality guidelines and SOP’s and other regulatory requirements.
- Track the receipt of third party samples against the shipping schedule and routine/stability sample requests escalating any delays in receipt of samples.
- Sample third party routine samples and distribute to the laboratories in a timely manner to prevent delays to batch release.
- Receive stability samples, reserve samples and retain samples from third party suppliers and store/distribute following site procedures.
- Co-ordinate sample shipments from Liverpool site to third party reciprocates following site procedures, ensuring efficient delivery.
- Submission of sample requests, collection of requested samples from formulation department and management of sample storage in support of site stability studies.
- Sample stability material at the respective time point using both aseptic and non-aseptic techniques, label the samples and distribute to the QC and Microbiology laboratories, adhering to the stability time point sampling windows.
- Escalation of any OOS/Atypical data points relating to stability studies or failure to comply with proceduralised stability study requirements to management.
- Participate; provide advice and technical support as required for deviations/ investigations.
- Ensure all documentation is completed correctly, accurately and in a timely manner and signed by the relevant personnel.
- Administration duties, order of materials and consumables and stock management
- GMP background essential – ideally Pharma industry
- Experience of Quality Control testing techniques and industry practices
- Experience of sample management
- Experience of using LIMS software/system – desirable