Sr. Business Consultant

Yash Technologies; Hyderabad; Vor Ort; INR 2.000.000 - 4.000.000; Vollzeit

Zusammenfassung

YASH Technologies, Inc. seeks a Lead Quality Management Domain Consultant with 10+ years of experience to advance quality-process assessment, operational improvement and digital-transformation initiatives for a global Healthcare and Life Sciences client.

The role requires strong domain knowledge and hands-on experience in regulated manufacturing environments with plant and laboratory visits. You will define requirements, support validation and drive practical improvements across QA, QC, CAPA,

Qualifikationen

• 10+ years of professional experience in QM within healthcare or life sciences.
• Exposure to regulated manufacturing environments and plant visits.
• Strong knowledge of GxP, 21 CFR Part 11 and validation principles.
• Experience in QA/QC, CAPA, deviations, audits and process improvements.

Aufgaben

• Assess end-to-end quality processes across plants, labs, warehouses and distribution.
• Conduct shopfloor observations, interviews and process workshops.
• Review nonconformance, deviation, CAPA, complaint, inspection and release processes.
• Document current and future state processes with clear requirements.
• Identify gaps in process, data, apps and integration.
• Define business requirements, user stories and acceptance criteria.
• Support testing, UAT, validation and implementation.
• Develop quick-win improvements and transformation roadmaps.
• Present findings to Quality, Manufacturing and IT leadership.

Kenntnisse

Quality management

GxP

Analytical skills

Stakeholder facilitation

Process improvement

Travel willingness

Tools

LIMS

eQMS

MES

WMS

SAP QM

Jobbeschreibung

We are looking forward to hire Quality Management (QM) Professionals in the following areas :

Lead Quality Management Domain Consultant, Healthcare and Life Sciences

We are seeking a Lead Quality Management Domain Consultant with 10+ years of experience to support quality-process assessment, operational improvement and digital-transformation initiatives for a global Healthcare and Life Sciences organization.

The candidate must possess strong quality-domain knowledge and practical experience in regulated manufacturing environments. The role requires the ability to visit manufacturing plants and laboratories, understand how quality processes are performed, identify operational and system gaps, and translate business challenges into practical improvement opportunities and structured requirements.

Key Responsibilities

• Assess end-to-end quality processes across manufacturing plants, laboratories, warehouses and distribution operations.
• Conduct shopfloor observations, stakeholder interviews and process workshops.
• Assess incoming, in-process and finished-goods quality processes.
• Review nonconformance, deviation, CAPA, complaint, inspection, testing and release processes.
• Document current-state and future-state processes.
• Identify process, control, data, application and integration failure points.
• Assess GxP, data-integrity and computerized-system considerations.
• Define business requirements, user stories and acceptance criteria.
• Support risk-based testing, UAT, validation and implementation.
• Recommend practical process, system and organizational improvements.
• Develop quick-win recommendations and Quality Management transformation roadmaps.
• Present findings and recommendations to Quality, Manufacturing and IT leadership.

Mandatory Requirements

• 10+ years of professional experience.
• Strong Quality Management domain knowledge.
• Healthcare, Medical Device, Pharmaceutical or Life Sciences experience.
• Manufacturing, plant or shopfloor quality-process exposure.
• Experience across Quality Assurance, Quality Control, inspection, nonconformance, deviation or CAPA processes.
• Knowledge of GxP, 21 CFR Part 11 and computerized-system validation principles.
• Prior client-facing experience in an IT services or consulting organization.
• Strong business-process assessment and requirements-analysis experience.
• Experience supporting testing, UAT, validation or implementation.
• Ability to work independently with plant, quality, laboratory and IT stakeholders.
• Strong analytical, workshop-facilitation and communication capabilities.
• Willingness to travel to client manufacturing locations.

Nice to Have

• Previous industry-side Quality Assurance or Quality Control experience.
• Medical-device manufacturing experience.
• Knowledge of ISO 13485.
• Experience with global or multi-plant quality-transformation programs.
• Exposure to SAP Quality Management.
• Working knowledge of LIMS, eQMS, MES or other quality applications.
• Experience with ERP, LIMS, MES, eQMS and WMS integrations.
• Relevant quality, regulatory, validation or auditing certification.

Our Hyperlearning workplace is grounded upon four principles

• Flexible work arrangements, Free spirit, and emotional positivity
• Agile self-determination, trust, transparency, and open collaboration
• All Support needed for the realization of business goals,
• Stable employment with a great atmosphere and ethical corporate culture