Lead – Quality Assurance| ArisGlobal | Bengaluru, Karnataka, India

Position: Lead – Quality Assurance

Location: Bengaluru, Karnataka, India

Essential Duties and Responsibilities

Plan audit schedule in accordance with published Audit Calendar
Conduct audits to ensure compliance and gaps in process implementation
Review project documents, artifact evidence of functions during audits for process compliance
Provide feedback to SEPG/Quality Manager on best practices for Quality Improvement
Publish audit report in a time bound manner as defined in QA Process
Seek and Review Corrections and Corrective Actions planned by the auditees and provide feedback
Work with stakeholders to ensure action plans are defined for addressing deviations and non-compliance issues and are implemented
Provide consultation on the process to projects
Recommend Process Improvements
Prepare audit calendar
Participate in Corrective and Preventive action activities.

10+ years’ experience in Quality Assurance
Pharmaceutical industry experience required.
Thorough knowledge of ISO 9001, ISMS 27001 and other applicable statutory and regulatory requirements
Certified ISO 9001 Lead/Internal Auditor training program
Thorough knowledge on organization’s Quality Management system
Thorough knowledge on Internal Audit process
Knowledge of audit & management terminology, leadership practices and principles
Knowledge of customer services practices and risk management techniques and methods
Knowledge of personnel management issues and evidence-based decision making
Knowledge of process approach
Metrics Analysis & Risk evaluation
RCA and CAPA management techniques.
Interaction with internal & external stakeholders

Leadership qualities
Proficient / Excellent Soft skills
Customer Centric
Good Communication Skills
Technically very strong – ability to learn and contribute to business requirements.
Updated on industry trends.
Customer satisfaction focus
Analytical

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