CSA Auditor, TraceLink

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation.

Key Responsibilities:

• Plan, conduct, and report CSA audits of TraceLink implementations, integrations, and supporting systems across global sites and third-party vendors.
• Evaluate system lifecycle documentation—including validation plans, risk assessments, IQ/OQ/PQ reports, user requirements, and traceability matrices.
• Ensure TraceLink environments (Track & Trace, Serialization, Compliance Reporting, etc.) align with 21 CFR Part 11, Annex 11, GAMP 5, and internal quality standards.
• Collaborate with IT, QA, Supply Chain, and vendors to identify and remediate compliance gaps.
• Assess change control, incident management, and periodic review processes for TraceLink and related systems.
• Provide expertise in CSA methodology—focusing on risk-based validation, automation, and efficiency improvements over traditional CSV approaches.
• Author and maintain audit reports, CAPAs, and follow-up documentation.
• Support internal training and continuous improvement in system assurance best practices.

Qualifications Required:

• Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field.
• 5+ years of experience in GxP computer system validation (CSV/CSA), including vendor and system audits.
• 2+ years of hands-on experience with TraceLink (serialization, compliance reporting, or integration modules).
• Strong knowledge of FDA 21 CFR Part 11, Annex 11, GAMP 5, and data integrity principles.
• Experience with audit preparation, execution, and CAPA follow-up.
• Excellent documentation and communication skills.

Preferred:

• Experience with pharmaceutical supply chain systems and serialization compliance.
• Prior experience auditing SaaS/cloud-based systems.
• Understanding of Agile, ITIL, or SDLC methodologies in regulated contexts.
• Relevant certifications (e.g., ASQ CQA, ISPE GAMP, RAPS, or equivalent).