Sr. Business Consultant
YASH Technologies · Hyderabad · onsite · Posted today
Undisclosed10–15 yrsfulltimeSourced from
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About this role
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
This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
AgileAuditingCfrISO 13485mesDistribution OperationsBusiness RequirementsCAPAintegrationsPlant QualityHealthcareERPQuality AssuranceQuality ControlManufacturingoperationsIT ServicesPharmaceuticalLife Sciences
About YASH Technologies
YASH Technologies
IT Services & Consulting
4.9k+
employees
1996
30 years old
Indore, Madhya Pradesh
India
About
YASH Technologies is a leading systems integrator and outsourcing partner that focuses on empowering its customers to drive enterprise-wide business transformation at scale.
Industries
IT Services & Consulting
Employee ratings
2,024 reviews
3.6/ 5
Culture
3.6
Career growth
3.1
Work-life
3.7
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