Merck KGaA

ISO Management Representative

Posted On

Feb. 27, 2025

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

Full-time

Apply By

March 18, 2025

Job Description

Job Description: ISO 9001:2015 Management Representative (MR)Job Title: ISO 9001:2015 Management Representative (MR)Location: Electronic City, BangaloreReports to: Solid line : Head of Quality & Regulatory COE and Dotted line: Head – Business Process ExcellenceDepartment: Business Process ExcellenceJob Summary:The ISO 9001:2015 Management Representative (MR) is responsible for overseeing and managing the implementation, maintenance, and continuous improvement of the SBS's Quality Management System (QMS) in compliance with ISO 9001:2015 standards. The MR will ensure that all quality-related activities align with the organization's goals, objectives, and regulatory requirements. This role requires close collaboration with all Centre of Excellence (COEs) to promote a culture of quality and drive process excellence.Key Responsibilities:QMS Implementation & Maintenance:Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 9001:2015 standards.Ensure that the QMS processes are established, implemented, and maintained effectively across the organization.Management Review:Organize and lead Management Review meetings, ensuring that top management is fully informed of the QMS performance, including any needed improvements.Prepare and present data on the performance of the QMS, including key performance indicators (KPIs), audit findings, and customer feedback.Internal Audits:Plan, schedule, and conduct internal audits to ensure the QMS meets ISO 9001:2015 requirements.Identify non-conformities and opportunities for improvement, and work with relevant departments to develop and implement corrective actions.Document Control:Manage the control of documents and records within the ManGo System, ensuring that they are accurate, current, and readily accessible to relevant personnel.Ensure that all quality-related documentation is in compliance with ISO 9001:2015 standards.Continuous Improvement:Promote a culture of continuous improvement within the organization by identifying areas for process enhancement and efficiency.Lead or participate in quality improvement projects, including root cause analysis and problem-solving activities.Training & Development:Provide training and support to staff on ISO 9001:2015 requirements and the organization's QMS.Ensure that all employees are aware of their roles and responsibilities within the QMS.Customer Satisfaction:Monitor and analyze customer feedback and complaints to ensure customer satisfaction.Implement corrective actions to address customer concerns and improve overall quality.External Audits & Certification:Serve as the primary point of contact for external auditors and certification bodies.Prepare for and coordinate external audits, ensuring that the organization maintains its ISO 9001:2015 certification.Qualifications:Education:Bachelor’s / Master's degree in any discipline.Experience:Minimum of 5-8 years of experience as a Management Representative, with a focus on ISO 9001:2015.Proven experience in managing a QMS and leading internal audits.Certifications:ISO 9001:2015 Lead Auditor.Six Sigma or Lean certifications are a plus.Skills:Strong knowledge of ISO 9001:2015 standards and requirements.Excellent communication, leadership, and organizational skills.Proficiency in QMS software and tools.Ability to work collaboratively with cross-functional teams.Personal Attributes:Detail-oriented with strong analytical skills.Proactive and self-motivated with the ability to work independently.Strong problem-solving skills and the ability to think critically.Commitment to upholding the highest standards of quality

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