More jobs:
CSV Quality Support Lead
Job in
Morristown, Morris County, New Jersey, 07960, USA
Listed on 2026-07-22
Listing for:
Veridic Solutions
Full Time
position Listed on 2026-07-22
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
This role oversees validation documentation (URS, IQ, OQ, PQ), risk assessments, change controls, CAPA, and audit readiness while ensuring compliance with FDA 21 CFR Part 11, GAMP 5, and other regulatory requirements.
Responsibilities- Lead Computer System Validation (CSV) activities.
- Ensure compliance with GxP regulations and quality standards.
- Conduct risk assessments and manage change controls.
- Implement CAPA and ensure audit readiness.
- Collaborate with Quality, IT, Engineering, and Validation teams.
- Experience in pharmaceutical, biotechnology, or life sciences environments.
- Strong knowledge of FDA 21 CFR Part 11 and GAMP 5.
- Experience with validation documentation and processes.
- Experience in leading cross‑functional teams.
- Strong communication and collaboration skills.
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