Senior Contract Development & Manufacturing Associate Remote 80% Onsite 20% RK8225 Contract 12 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. The Sr Associate Contract Development & Manufacturing provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality Key Responsibilities: The successful candidate is expected to own and execute various quality record types, including Deviations (Major/Minor), CAPA, SICAR, Change Control and perform metrics oversight responsibilities. Liaise with Third Party CDMOs to maintain and monitor systems to ensure all record received are appropriately investigated and concluded per quality standards and procedures. Support/Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools. Optimise deviation management, corrective and preventive actions effectiveness to prevent reoccurring events. Report Third Party CDMO site performance metrics to site lead; identify improvement opportunities for site performance. Coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT) Oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team Facilitation of cross-functional teams (internal and external to External Supply). Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions. Participate in the assessment or implementation of continuous improvement projects or initiatives. Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting. Education and Experience: Bachelors Degree (L8) in Business Administration, Engineering or Science-related field 5 years of experience in GMP protein, API, DS, DP or packaging manufacturing environment Experience in roles requiring knowledge of cGMP principles, FDA and other regulatory agency guidelines, and validation principles Understanding of applicable manufacturing/testing processes (i.e. protein, API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Experience with supporting/managing Third Party CDMO sites Demonstrated experience with QMS & Digital tools including Veeva Vault, TrackWise, AI software. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.