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 Scheduling and 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.
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.