Role & responsibilities

Corporate QMS & Harmonization Support Corporate QMS framework; harmonize site processes; identify gaps/duplication; establish standardized process maps, workflows and responsibilities; monitor implementation and effectiveness; identify systemic issues and share best practices.

QMS Process Governance Support oversight of Deviation/Non-Conformance, CAPA, Change Control, QRM, Audits, DMS, Training, OOS/OOT, Supplier Quality, Quality Metrics/Management Review and QMS Effectiveness. Monitor KPIs, trends, actions and escalations. Quality Digitalization Coordinate the Quality Digitalization Roadmap and automation opportunities; define current/future-state workflows; support DMS, eQMS, LMS, LIMS, dashboards and other quality platforms; coordinate QA/IT/vendor requirements; monitor milestones, risks, issues, adoption and stabilization.

URS & Digital Process Design Coordinate URS and requirements; translate QMS needs into measurable system requirements; define workflows, approvals, roles, notifications and escalations; ensure GMP, Data Integrity,



electronic records/signatures, audit trails, access controls, segregation of duties, retention, backup/recovery and business continuity are addressed.

CSV/CSA & Digital Compliance Support risk-based CSV/CSA; coordinate review of risk assessments, URS/FRS/configuration requirements, test scripts, UAT, IQ/OQ/PQ, traceability and validation summaries. Support lifecycle control, change/deviation management and periodic review.

Data Integrity Support ALCOA+ implementation and controls for access, role-based security, audit trails, e-signatures, data review, retention, backup, migration and archival; support DI assessments/remediation and risks arising from manual-to-digital transformation.

QMS Metrics, Analytics & Dashboards Develop standardized corporate QMS metrics; consolidate site data; trend CAPA, deviations, change controls, audits, documents, training, QMS effectiveness, digitalization, system performa

📌 Asst Manager (Pune)
🏢 MJ Biopharm
📍 Pune