QA Compliance Specialist Job at Katalyst Healthcares & Life Sciences, Indianapolis, IN

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  • Katalyst Healthcares & Life Sciences
  • Indianapolis, IN

Job Description

  • 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.

Job Description



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+).

Additional Information



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

Job Tags

Contract work, Immediate start,

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