Job Title: Stability Coordinators
Department: Analytical Services
Reporting to: Team Leader
Responsible for (staff): N/A
General Purpose of Role:
- To organise and manage all stability studies within the Analytical Services department.
- To ensure compliance with relevant Company, local and international Regulatory and Client requirements at all times. To ensure that stability time points and sample pulls comply with relevant procedures and Client expectations and data is reported in line with Technical Agreements, Internal procedures and client expectation.
- Responsible for leadership of the stability study management within Analytical Services Group ensuring timely co-ordination of routine stability analysis, with respect to set down and pull dates in line with business needs.
- To lead and drive the management of stability studies within Analytical Services to achieve the required business standards in terms of quality, safety, KPI’s, etc.
- To maintain stability inventory and facilities.
- To generate and authorise technical documentation (inc. stability protocols and stability reports) and to routinely participate in review procedures in relation to stability testing activities. This may extend to other areas within the Department, as required.
- To prepare technical documentation within the Department, as required.
- To train others as required, to ensure that all members of the Team are adequately trained in the use and running of the stability management systems.
- To maintain a thorough understanding of international regulatory and ISO requirements pertinent to the role and to ensure that this information is made available to the team, with departmental procedures and the principles of Good Manufacturing Practice.
- To ensure that all stability study co-ordination activities including those of sub-contract facilities providing a service to the Team and co-ordination team investigations, deviations and change controls are complied with, subject to there being no attenuating circumstances.
- Degree educated in a scientific subject (preferably Chemistry or Microbiology)
Previous Work Experience:
- Previous experience in a GMP pharmaceutical laboratory environment.
- Experienced in co-ordinating stability studies.
Specific Knowledge / Skills Competence:
- Understands the stability process within a GMP manufacturing facility
- Knowledge of international regulatory and ISO standards in relation to the stability processes.
- Lead by example