Related skills
gxp csv lims 21 cfr part 11 bsi📋 Description
- Provide QA support for GLP/GCLP studies ensuring data integrity.
- Plan and execute internal audits; create schedules and draft reports.
- Review SOP alignment, version control, and governing documents.
- QA review of clinical/protocol SAP/SAR; verify consistency with SOPs.
- Review experiment and batch records; ensure data traceability (ALCOA+).
- Prepare audit checklists and pre-audit packages; draft summaries.
🎯 Requirements
- Bachelor’s or Master in Life Sciences, Pharmacy, Biology, or Chemistry.
- 4+ years in life science GxP with CRO experience preferred.
- Hands-on with ICH-GCP (E6) and 21 CFR Part 11.
- Knowledge of GxP, GLP, GMP, GCLP; ALCOA+ and data governance.
- Experience with LIMS/BSI and data integrity reviews.
- Strong written/verbal communication and deadline-driven.
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Data Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!