Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Support timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) and ensure alignment with quality and regulatory expectations prior to release and/or approval.
Maintain organization of project deliverables for external partner project using applicable tools.
Identify and communicate quality risks in a pro-active and collaborative manner maintaining the business interests of the Organization and consideration of suitable outcome for the projects.
Participate in and support batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies.
Develop trusting team partnerships to ensure highly collaborative project outcomes.
Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s).
Requirements:
Knowledge of EU and FDA guidance’s.
Experience in a GMP environment.
Aseptic processing experience.
Project Management Experience preferred.
Minimum Education: Bachelor’s degree in science related field.
Years Experience: 6+ years.