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.