• Hands-on OSD viewing, review, interpretation, and gap analysis.
• Strong working knowledge of QSD review and compliance monitoring.
• Ability to identify and fill gaps in process documents without changing approved business intent.
• Good written and verbal communication, including professional stakeholder follow-up.
• Good proficiency in Microsoft Excel, including data validation, formulas, PivotTables, lookups, conditional formatting, and tracker preparation.
• Good proficiency in Microsoft PowerPoint for audit summaries, compliance dashboards, and leadership-ready presentations.
• Ability to understand requirements, evidence, controls, process flows, and approval matrices.
• Working knowledge of audit methodology, risk identification, root-cause analysis, CAPA tracking, and document control.
• Robust attention to detail, analytical thinking, organization, and ability to manage multiple review deadlines.
Responsibilities
• Review Operations Standards Documents (OSDs), Quality Standards Documents (QSDs), SOPs, policies, process maps,
and related controlled documents for completeness, accuracy, consistency, and compliance alignment.
• Analyze OSD content and supporting evidence to identify control gaps, missing information, outdated references, process deviations, and documentation inconsistencies.
• Partner with process owners to close gaps in process documents, update required sections, and maintain clear version history and approval evidence.
• Perform ongoing compliance reviews and sample-based checks to assess adherence to QSD, approved processes, contractual requirements, and applicable internal standards.
• Support internal and external audits by preparing evidence, validating documentation, tracking observations, and coordinating timely closure of action items.
• Facilitate approved process and documentation changes, communicate requirements, and monitor implementation through closure.
• Review and comprehend business, regulatory, contractua
📌 Assistant Manager (India)
🏢 EXL
📍 India