QA Compliance Specialist

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Roles & Responsibilities:

• GMP Experience.
• Minimum 8+ years in a GMP-regulated biopharmaceutical environment.
• Quality Assurance Experience .
• At least 2+ years specifically in a QA role.
• QA Compliance Knowledge.
• Strong knowledge of QA Compliance systems including.
• Quality Management Review (QMR).
• Annual Product Quality Review (APQR).
• Self-inspections.
• Audit readiness.
• In-depth understanding of FDA/ICH/EU cGMP regulations and guidelines.
• Data Integrity.
• Experience with Data Integrity principles (ALCOA+).

All your information will be kept confidential according to EEO guidelines.