INDUSTRIES

QA and Regulatory Affairs

Astrix has been successfully placing candidates in companies in regulated industries for over a decade. Our recruiters place a full range of regulatory affairs, quality assurance and document control specialists in the pharmaceutical, biotechnology and medical device industries. We work closely with each candidate and client in order to assure that the needs of both are met. Skills and Experience:

• Regulatory Affairs
• IND, NDA, ANDA, BLA
• 510 (k) Submissions
• Document Review and Editing
• GMP, GLP, GCP, ICH
• CMC Writing & Documentation
• CAPAs
• Drug Master Files
• Labeling
• Class I, II, III Devices
• Quality Assurance
• FDA Audits
• Internal & External Audits
• Batch Record Reviews
• SOP Writing & Review
• Out of Specification (OOS)
• Analytical Data Review
• Document Control
• Validation Protocol
• Quality Systems