Serve as a quality assurance subject matter expert, answer questions regarding QA, procedures and training.
Create, review, control, and/or approve documents required for GxP compliance.
Assist management with awareness of compliance issues.
Assist with preparing and responding to customer and regulatory agency requests and inspections.
Review site quality policies and procedures and ensure consistency of content of standards with GxP requirements. Present recommendations and changes to management.
Assist with performing quality systems audit (internal and vendor).
BSc or MSC degree
3+ years in pharmaceutical or bio lab expereince
Experience in FDA Regulations and Pharma / Biotech Quality Systems
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