Grifols Shared Services North America, Inc Quality & Compliance Specialist in los angeles, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Primary responsibilities for the role:
Coordinate and/or complete Site Master Files (SMFs)
Possess strong written and verbal communication skills that are required for crafting, writing, reviewing and/or approving responses and CAPA plans.
Provide on-site support during inspections by European regulatory authorities.
Assist the plasma group in maintaining operations that are compliant with European regulations.
Recognize areas of improvement and offer solutions to enhance compliance with European regulations.
Coordinate and/or complete responses to audits by European regulatory authorities.
Assist the Plasma Master File (PMF) holder in gathering information necessary to update regulatory authorities.
Act as a liaison to Biomat S.A. regarding compliance with European regulations.
Maintain various databases necessary to assure on-going activities are correct and appropriate.
Identify trends in regulatory observations.
Provide reports in various forms to various audiences to keep the plasma organization informed of activities occurring with regard to European compliance.
Interface with various levels and groups (social and economic) throughout the organization
Manage multiple tasks with competing demands and deadlines
Assess internal corporate audits to provide continuous surveillance of plasma suppliers to Biomat S.A.
BS degree is required, with a preference for an MS degree in a life science field.
4 years of directly related experience.
Candidate must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
Candidate must know the European Pharmacopoeia (EP) as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
Positon requires substantial travel.
Learn more about Grifols
Req ID: 123607
Type: Regular Full-Time
Job Category: Quality