Senior Technical Specialist Quality Operations
MSD
Cork
Job Description. Our Company in Cork are hiring a Senior Technical Specialist within the Lab Operations Technical IPT. This new position requires someone with strong technical knowledge and experience with lab systems (including Data Integrity requirements) to provide multidisciplinary expertise and technical support to the technical IPT and commercial testing laboratories. The Senior Technical Specialist will provide technical expertise and coaching to the Quality Laboratories for routine technical support and investigations. The Senior Technical Specialist is accountable for the effective and efficient running of projects within cross-functional multi-skilled teamwork environment, collaborating effectively with stakeholders. The Technical Specialist will support the deployment of the Digitalisation initiatives journey while embedding a culture that supports a “Lab of the Future” vision. This consists of personal accountability and responsibility, continuous self- development and colleague collaboration in an open and trusting environment where all colleagues are comfortable to voice their opinions. What you will do: Good knowledge of protein chemistry and analytical techniques such as HPLC, SDS-PAGE, IEF, CE, ELISA, Bioassay and compendial methods. Abreast with EU/US regulations for analytical and compendia methods within in GMP environment. Provide technical expertise and coaching to support lab operations. direct the delivery and deployment of projects whilst adhering to project timelines through the use of project management tools. Knowledge of SDLC Lab System lifecycle management in GMP environment and 21 CFR/DI requirements. Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, in accordance with GDP (good documentation practice) and site procedures. direct cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other Company's Sites and contract laboratories as required. Lead continuous improvement initiatives to drive efficiencies within the department. Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures. What skills you will need: Degree or 3rd level qualification (Science, Engineering, Quality. Knowledge of protein chemistry and diagnostic techniques such as HPLC, SDS-PAGE, IEF, CE, ELISA and compendial methods. Knowledge of Lab Systems and equipment qualifications/decommissioning in GMP environment. Experience is leading/co-ordinating projects in face paced environment. Desirable: Ph.D./M.Sc. qualification (Science. Knowledge of and experience in applying Six Sigma and Lean methodologies. Project management qualification such as Project Management Professional etc.
1153 days ago