Stability and Support Co-ordinator

4 weeks ago


Liverpool, United Kingdom Adecco Full time

Immediate Start 4 Month Contract

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 guidelinesand SOP's and other regulatory requirements.

**Accountability Description**

1 To track the receipt of third party samples against the shipping schedule and routine/stability sample requests escalating any delays in receipt of samples to the stability manager. Sample third party routine samples and distribute to the laboratoriesin 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.

2 To initiate stability studies according to the annual requirements through writing protocols, liaising with QA and/or site planning department to identify batches, where required. To sample stability material at the respective time point using both asepticand non-aseptic techniques, label the samples and distribute to the QC and Microbiology laboratories, adhering to the stability time point sampling windows.

3 Escalation of any OOS/Atypical data points relating to stability studies or failure to comply with stability study requirements to management. Participate; provide advice and technical support as required for deviations/ investigations.

4. Manage the storage, annual inspection and disposal of the final product retain samples on behalf of the site Qualified Person(s)

***JOB CRITERIA**

The job holder is responsible for receipting QC samples from 3rd parties and subsequent delivery to the QC labs which will be measured through by the lead times for the batch release.

The job holder will be responsible for the coordination and management of the site stability programme. This will be demonstrated by the adherence to the stability time point sampling windows.

The job holder is to liaise with QA, Supply Chain and the QC labs for the receipt of 3rd party samples and for the maintenance of the site stability study programme

The job holder identifies best practice and ensures that it is appropriately shared.

**This role is a contract for 11 months and would be suitable for a graduate or lab technician.**

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.


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