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 performance and improvement; develop dashboards and identify emerging risks.

Continuous Improvement Simplify and standardize QMS processes; eliminate redundant/manual activities through automation; support Lean/continuous improvement; measure advantages; support QMS maturity assessment and Right First-Time culture.

Audit & Inspection Support Support regulatory/customer audits for QMS and computerized systems; coordinate evidence; review observations; track CAPA/remediation; identify recurring cross site issues and support inspection readiness.

Vendor & Project Management Support solution evaluation, demonstrations and functional/technical assessments; coordinate vendors; monitor milestones, deliverables, risks, issues and dependencies; support vendor performance evaluation and project documentation.

Change Management & User Adoption Support stakeholder engagement, communication, role-based training, user awareness, adoption monitoring, feedback and transition from manual to digital

Experience: 8 to 10 years in Pharmaceutical/Biopharmaceutical QA, with strong GMP/QMS experience;

📌 Asst Manager / Dy Manager Corporate QMS and Quality Digitalization (Pune)
🏢 MJ Biopharm
📍 Pune