7-10 years of experience in CSV and GxP compliance validation activities across the SDLC.
Proven experience with Manufacturing, MES, and Data Platform Applications in GxP settings.
Deep understanding of FDA and global regulations related to GxP compliance.
Strong skills in validation documentation, including compliance plans, test protocols, and reports.
Demonstrated expertise in risk-based validation and risk management principles.
Effective leadership skills to mentor and guide cross-functional teams.
Experience with Agile tools such as Jira, Xray, or qTest.
Strong verbal and written communication skills in English.
Responsibilities
Lead validation activities for GxP systems with minimal supervision.
Support global and regional GxP computerized systems in manufacturing environments.
Review and ensure compliance of validation documentation and deliverables.
Apply risk management practices in validation activities.
Coordinate projects while communicating status, risks, and issues to stakeholders.
Write and maintain various compliance documentation, including test plans and procedures.
Foster collaborative partnerships across teams to support business objectives.
Benefits
Opportunities for professional development and mentorship.
Collaboration with cross-functional and external teams.
Support for global GxP compliance initiatives.
Work with leading-edge technology and tools.
Full Job Description
Summary :
Roles & Responsibilities :
Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
Demonstrated application of risk-based validation and risk management practices.
Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.
Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs).
Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
bility to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.
Primary Language required: English. Strong verbal and written communication skills.
bility to work with dispersed/remote teams and support several projects simultaneously.
Experience with Acquisitions/Separations/ Divestiture efforts is desirable.
