CSV Lead Consultant

We are looking for a CSV Lead Consultant with deep expertise in Computer System Validation within the life sciences domain. The ideal candidate should have over 10 years of experience validating GxP-regulated applications and strong exposure to compliance frameworks such as GAMP.

Primary Responsibilities:

Execute and manage end-to-end validation activities for GxP-related applications (e.g., SAP, MES, Product Serialization).

Conduct GxP risk assessments, change management, and compliance analysis.

Author and review validation deliverables such as Validation Plans, Protocols, and Summary Reports.

Manage traceability from requirement specification through testing and final compliance.

Lead Agile and Waterfall-based validation efforts and ensure documentation completeness and accuracy.

Provide guidance on test design, execution, and defect management.

Serve as the single point of contact for compliance and assurance services across functional/geographic scope.

Perform roles such as CSA (Computer System Assurance), Validation SME, and Test Manager as per CSL QMS standards.

Tools & Platforms:

JIRA, ALM, Document Management Systems

Veeva, Argus

Good to have: Experience with US-DSCSA implementations

Soft Skills:

Strong communication and leadership skills

Ability to manage stakeholder relationships and resolve feedback constructively

Strong documentation and analytical capabilities