Key Roles/Responsibilities: Roles/Responsibilities:
Departmental Operations:
* Perform assigned work as agreed with the project lead and/or Analytical Development Manager. Ensure efficient use of time to complete the assigned objectives
* Maintain laboratory areas, ensuring procedures are complied with to meet client, regulatory GMP and safety requirements.
* Provide training and troubleshooting support to production and stability Quality Control groups.
* Provide QC support (if required.)
* Engage in specified compliance and improvement projects.
* Provide cover for other Analytical Development Scientists as required.
* Ensure economic use of labour, materials, energy and services, proposing and implementing measures for cost reduction and waste minimisation to meet the department and site targets.
* Identify opportunities for improved methods of working to enhance efficiency, cost control and safety/GMP performance.
* Support training of new members of staff to the company / department.
Project Delivery:
* Responsible for ensuring that assigned project deliverables are fully completed on time.
* Lead aspects of projects as appropriate and in agreement with the Analytical Development Manager.
* Plan and carry out work, as agreed with the project lead, to ensure effective project progression in line with customer requirements.
* Support method development, technical transfer, qualification and validation activities.
* Provide analytical development project support, ensuring compliant introduction into QC, production and stability groups – have involvement in decisions on scheduling of development, technical transfer and validation in conjunction with other technical staff.
* Workload planning with other staff to ensure required timelines are met.
* Provide QC support if required.
* Client communication as required, in a professional manner.
Quality:
* Ensure timely close out of deviations, change controls and commitment tracking.
* Uphold cGMP principles and ESH standards, continually seek opportunities to improve and enhance standards, and encourage other staff to do likewise.
* Record all laboratory work in standard official notebooks and compile results and observations for incorporation into technical reports. Adhere to the relevant procedures.
* Follow all appropriate protocols and procedures as required for the work undertaken.
* Ensure accuracy of raw data and analytical interpretations
Key Competencies:
* Teamwork - As a team member, the ability and desire to work cooperatively with others on a team
* Communication - The ability to ensure that information is passed on to others who should be kept informed.
* Organisation – The ability to efficiently plan and prioritise across a range of timeframes, making efficient use of time.
* Customer Awareness - The ability to demonstrate concern for satisfying one’s external and/or internal customers.
* Attention to Detail - Ensuring that one’s own and others’ work and information are complete and accurate
* Problem Solving – The ability to accurately assess a situation and derive a positive outcome .
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