Team Member Qualifications
Job Description
Job Summary
This role is for a Qualification & Validation Specialist responsible for executing equipment and system qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The position involves coordinating with vendors and cross-functional teams, preparing risk assessments, SOPs, validation programs, and master plans, and ensuring compliance with cGMP standards. You will contribute to regulatory readiness by compiling qualification documents, supporting audit responses, and coordinating CAPA, incidents, and deviations. The role emphasizes safety risk assessments, digital system implementation (eVal), and vendor audits. Additionally, you will assist in preparing corrective actions, drive safety awareness, and support continuous improvement in qualification and validation practices.
Roles & Responsibilities
• You will be responsible for executing qualification protocols (IQ, OQ, PQ), coordinating with vendors and cross-functional teams.
• You will be responsible for compiling qualification documents, preparing risk assessments, SOPs, validation programs, and master plans.
• You will be responsible for executing equipment requalification as per schedule and updating qualification schedules.
• You will be responsible for assisting in audit responses, coordinating with QA for CAPA, incidents, deviations, and audit reports.
• You will be responsible for preparing master documents (SOPs, operating instructions, VMPs) and coordinating risk assessments for equipment/systems.
• You will be responsible for assessing safety risks, driving implementation of safe procedures, and creating awareness among team members.
• You will be responsible for supporting digital system implementation (eVal) and coordinating URS, DQ, and quantitative risk assessments with production and engineering.
• You will be responsible for coordinating with QA and engineering for cGMP document approvals and vendor audits.
Requirements
Function: Other
Experience Level: Mid-Senior Level