Veeva Consultant
Infosys
Consultant – Pharmaceutical QMS (GxP) We are seeking a highly experienced IT Consultant (10+ years) to lead the design and implementation of Quality Management Systems (QMS) in GxP-regulated pharmaceutical environments. This role combines deep expertise in business analysis and eQMS implementation with strong advisory capabilities in process harmonization and regulatory compliance. As a key member of our Life Sciences R&D consulting team, you will play a pivotal role in delivering scalable, compliant QMS solutions. You’ll lead quality initiatives, facilitate cross-functional workshops, and help shape global quality processes aligned with regulatory standards such as ICH, FDA, EMA, MHRA, and ISO 9001.
Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compliant QMS frameworks tailored to client needs. Collaborate with cross-functional teams to gather and document requirements across functional, migration, and integration workstreams. Translate business needs into functional specifications using tools like JIRA and HP ALM. Implement and support supplier qualification, audits, performance monitoring, and risk management processes. Integrate supplier quality workflows into enterprise QMS platforms.Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compliant QMS frameworks tailored to client needs. Collaborate with cross-functional teams to gather and document requirements across functional, migration, and integration workstreams. Translate business needs into functional specifications using tools like JIRA and HP ALM. Implement and support supplier qualification, audits, performance monitoring, and risk management processes. Integrate supplier quality workflows into enterprise QMS platforms.
A degree in a technical, scientific, or clinical discipline is preferred.
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