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.
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 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.40%
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 aseptic and non-aseptic techniques, label the samples and distribute to the QC and Microbiology laboratories, adhering to the stability time point sampling windows.40%
3 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.10%
4.Manage the storage, annual inspection and disposal of the final product retain samples on behalf of the site Qualified Person(s)10%
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.
-Secondary Quality Assurance
-Supply Chain including the QC Planner
-Microbiology, QC Analytical and Bioassay Associates
-QC Lab Assistants
Issuing QC routine samples and stability samples to the laboratories for testing, within set time frames.
To provide advice and technical support as required for improvement projects/ deviations/ investigations.
The job holder is involved in problem solving where an error has been identified following 3rd party sample receipt.
The job holder identified potential innovations/ improvements for the department.
The job holder identifies and plans for stability aseptic and non-aseptic activities to be performed within the allowed time frames.
Knowledge, Skills & Competencies
-Fluency in English
-cGMP background in the Pharmaceutical industry
-Experience of Quality Control testing techniques and industry practices
-Proven time management skills for planning and schedule of work
-Proven Communication skills both written and verbal.
Minimum Education Requirements
-Graduate Level in related discipline
Minimum Experience Requirements
Adecco is acting as an Employment Business in relation to this vacancy. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
- Quality Control