Senior Contract Development & Manufacturing Associate

Senior Contract Development & Manufacturing Associate
Remote 80% Onsite 20%
RK8225
Contract 12 months
Dublin


We’re 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.

• Bachelor’s 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.