Preference having exposure of regulatory inspections. Handling and controlling of daily production activities, improvement initiatives, interdepartmental coordination and manpower handling.
Responsible for the coordination of supportive equipment and process validation activities such as testing, calibration, scale-up, engineering and validation studies, and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.
The MDR Lead partners closely with cross functional teams to deliver high-quality, decision-ready clinical data in support of Amgen’s development strategy.
This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures.
A Post-graduate / Graduate degree in Chemistry / Pharmacy / Life Sciences or others. Candidate should have understanding of various departments in pharmaceutical company.