Senior Specialist, Warehouse Compliance

Responsibilities:

• Lead the development, review, and periodic revision of warehouse SOPs, forms, logs, and GMP documentation.
• Manage warehouse training programs, qualification matrices, training records, and personnel qualification compliance.
• Lead warehouse inspection readiness and coordinate internal, external, customer, and regulatory audits and inspections.
• Lead and support deviation investigations, CAPA management, effectiveness checks, change controls, and quality risk assessments related to warehouse operations.
• Ensure compliance with GMP, GDP, Data Integrity, and applicable regulatory and company quality requirements.
• Manage GMP record review, archival, retention, retrieval, and documentation control activities.
• Monitor quality and compliance KPIs, prepare periodic reports, and support management review and continuous improvement activities.
• Administer warehouse system access controls, user role assignments, and periodic access reviews.
• Provide daily GMP, non-GMP, and compliance support to warehouse operations and cross-functional stakeholders.
• Manage warehouse facilities, equipment, infrastructure, and building access control systems to ensure operational readiness.
• Coordinate preventive maintenance, calibration, inspection, repair, validation, qualification, and service activities for warehouse facilities and equipment.
• Manage site-wide fixed asset activities, including asset labeling and inventory verification, as well as warehouse consumables procurement and non-SAP inventory replenishment.
• Collaborate with QA, Engineering, Validation, EHS, IT, Procurement, Finance, and external service providers to ensure compliance and operational effectiveness.
• Complete other work assigned by the supervisor.

Requirements:

• Diploma in Logistics, Supply Chain Management, Warehouse Management, or equivalent qualification, with relevant warehouse, logistics, GMP, or quality systems experience preferred.
• Strong documentation management, audit support, deviation investigation, CAPA and change control management skills, with the ability to work independently, effectively coordinate cross-functional activities, and demonstrate strong analytical and continuous improvement capabilities.
• Experience in warehouse start-up, project implementation, validation, or equipment/facility qualification is preferred.
• Strong communication, stakeholder management, problem-solving, and cross-functional collaboration skills.