What are your responsibilities?

As Manufacturing Sciences Specialist, you are in charge to

• Uses Six Sigma and DMAIC methods where appropriate.
• Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s).
• Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.
• Ensures and defends the Compliance to cGMP's, GDP's, licenses and procedures by defining, implementing and maintaining appropriate SOP's and training.
• Favors communication, critical thinking, problem solving and teamwork across all manufacturing facilities.
• Defends investigations in front of regulators during audits.
• Uses QbD, DIDOV, Lean and implements new technologies (including PAT) where appropriate.
• Conducts risk analyses for existing manufacturing processes as well as for new/upgraded processes (Capacity increase, Change Request, …), evaluate and implement actions to mitigate/reduce the identified risks.
• Defines tasks/experiments to be performed, provides required documentation and leads the project from start to the implementation, including the submission preparation.
• Is involved in technology transfers, CMO related activities.
• Ensures training of personnel on Scientific & Technical topics.