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Katalyst CRO · 2 months ago

GMP Senior Auditor

Paramus, NJ

Contract

Onsite

Mid, Senior Level

3+ years exp

Katalyst CRO is seeking a GMP Senior Auditor to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role involves planning, conducting, and reporting on audits while supporting the Pharmaceutical Quality System by identifying gaps and driving continuous improvement.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance

Comp. & Benefits

Responsibilities

Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers

Prepare detailed audit plans, checklists, and schedules

Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines

Review and approve deviations, CAPAs, and change controls

Document audit observations and issue formal audit reports

Track and verify implementation of corrective and preventive actions (CAPAs)

Provide guidance on compliance requirements and audit readiness

Support regulatory inspections and customer audits

Identify systemic issues and recommend process improvements

Stay updated on evolving regulatory requirements and industry best practices

Qualification

Radiopharmaceuticals experienceQuality experienceRPT cGMP knowledgeAuditing experienceASQ Certified Quality AuditorISO 9001 Lead AuditorGCP/GMP auditing certificationsAnalytical skillsReport-writing abilitiesAttention to detailCommunication skills

Required

Must Have Radiopharmaceuticals and Quality experience

Bachelor's degree in Life Sciences, Pharmacy, or related field

35 years in Radio Pharmaceuticals, with at least 2 years in auditing

Strong knowledge of RPT cGMP, GDP, and global regulatory requirements

Excellent attention to detail and analytical skills

Strong communication and report-writing abilities

Ability to travel (up to 10%) for audits

Preferred

ASQ Certified Quality Auditor (CQA)

ISO 9001 Lead Auditor

GCP/GMP auditing certifications

Company

Katalyst CRO

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.

South Plainfield, New Jersey, USA

51-200 employees

http://katalysthls.com

Funding

Current Stage

Growth Stage

Leadership Team

John Patil

Recruiter, Pharma/CRO Staffing Division

Recent News

Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal

2024-04-07

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