Ongoing Stability Analyst

1 week ago

City of Kingston upon Hull, United Kingdom SRG Full time
Job Description

Key Responsibilities/ Accountabilities


  • Testing of ongoing stability samples within the laboratory
  • Day to day prioritization and organization of individual workload to ensure that customer service and stakeholder needs are met.
  • Develop, implement, and monitor the progress of their individual Personal development clan.
  • To ensure that relevant data is checked, approved, recorded and available for inspection in accordance with Good Manufacturing & Good Laboratory Practices.
  • To maintain high standards of laboratory / office housekeeping in their work areas.
  • To understand and follow all necessary Health & Safety systems and ensure that all work is consistent with safe working practices.
  • Ensure compliance with Training.
  • Taking ownership for training, seeking out opportunities to fulfil individual training needs.
  • To ensure cGMP compliant delivery of their activities. To understand & contribute to agreed metrics for the monitoring of performance & delivery.
  • To support the continuous development of wider OGS/QC operations and continuous improvement programs.
  • To support the application and maintenance of laboratory quality systems.
  • Responsible operator tasks for basic equipment within the laboratory, including SOP writing and maintenance in relation to the equipment.
  • Apply & maintain the cGMP processes/ documentation / systems that are relevant to their area, and / or as may be delegated by laboratory management.
  • Identify and escalate focused improvements to activities within their section where viable.
  • Provide support to Regulatory Authority inspections as required.
  • To ensure individual activities are aligned with those of the wider QC/OGS laboratory.
  • To deliver assigned tasks as required to meet or exceed OGS Key Performance Indicator targets
  • To ensure that OGS equipment and systems are maintained / calibrated / Qualified to appropriate standards.
  • To communicate issues effectively and appropriately to ensure timely resolution with all relevant parties whilst maintaining the positive image of and the OGS function.
  • To be flexible to the needs of the business, moving across areas of the laboratory as required.
  • Ensuring audit readiness is always maintained.
  • To provide support for OGS Line Management as appropriate.


SKills


  • Degree level qualification and/or relevant and appropriate demonstrable skills & experience
  • Good delivery of core skills
  • Demonstrable or transferable skills relevant to the delivery of OGS activities
  • Demonstrable skills in working within a multi-level team environment
  • Ability to work on own initiative and within a team of people
  • Basic awareness of troubleshooting.
  • Good communication skills, both written and oral with sound presentation skills.
  • Good IT skills required, such as Excel, Word, PowerPoint. Chrome Leon and SAP would be advantageous.

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