Back to jobsEnsure sterile products compliance with necessary regulations (ISO, USP, FDA, EMA, ANVISA, etc.) and applicable testing methods for use in pharmaceutical and medical device applications.
Support Maintenance of Business (MOB) tech. transfers or New Products Introduction (NPI) from R&D at multiple internal and contractor manufacturers’ locations while ensuring uninterrupted product supply.
Provide technical guidance and input to the critical process parameters, qualifications, and improvement of aseptic processes.
Develop, manage and sustain documentation of tech. transfer packages to ensure high level accuracy and consistency including technical and compliance oversight to protocol generation, report closeouts and technical packages.
Provide technical support for the vendor evaluation and selection process.
