Job descriptionThis resource will be expected to lead the implementation process for new laboratory equipment installations within the analytical teams of QC and Analytical R&D (AR&D), utilising support from other departments such as QA, IT and analytical as required, so needs to have specific knowledge of the end-to-end equipment installation and qualification process for analytical instrumentation in a cGMP environment.Responsibilities:The key responsibilities of the Senior Laboratory Analyst – shall include but shall not be limited to:· Lead role in the implementation and qualification of analytical instruments, and in their routine/periodic maintenance.· Develop standard operating procedures, specifications and local analytical methods.· Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.· Publish and analyse reporting results into a computer storage system (LIMS), as well as performing testing using automated systems.· Managing equipment supplier relations, for new equipment and software to be used in the Laboratory· Lead and coordinate deviation investigations and record any errors encountered, as per procedures and training.· Establish and maintain internal and external communication with stakeholders from adjacent departments, supporting functions and external vendors.· Assist in the training of other personnel and as their level of skill develops, may be responsible for the full training of other Laboratory personnel.· Foster and support a culture of growth, enablement and high performanceBasic Requirements:· Minimum BSc (Hons) in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 5 years pharmaceutical experience.· Experience of HPLC/GC testing and set-up for different analytical processes.· Experience in a small molecule pharmacology environment.· Comprehensive knowledge of quality control operations.· Understanding of multiple instrument platforms, vendors and associated software applications.Additional Skills/Preferences:· Demonstrated leadership competencies by leading a team or department close to QC, QA and/or IT operations.· Proven to be an excellent communicator and motivator to drive interdepartmental initiatives.· Proven ability to implement changes in operational, technology and business process workflows in a pharmaceutical environment.· Demonstrated expertise of Data Integrity/Orchestration and its application in (Pre-) Digital Laboratory Operations.
