Merck KGaA

Senior Executive- Quality Management System

Posted On

June 25, 2024

Location

Bangalore, Karnataka

Experience Level

E - Professional (10+ years)

Job Type

full-time

Apply By

July 16, 2024

Job Description

Roles and Responsibilities:Manage customer audits/ regulatory audits/Certifying Body audits through planning, execution and closing of audits. Liaison with external agencies / corporate QA for maintaining the ISO Certifications and adding required certifications. Responsible for monitoring customer satisfaction indices, identifying and implementing action plan. Communicate customer notifications as neededImplement and sustain QMS across the organization. QMS is governed by ISO9001:2015 as well as LS QMS and 21 CFR820/ISO13485:2016: Plan for Internal Audit and Execution. Plan MRM with Site LT and prepare/submit IMR report and communicate to corporate quality. Monitor and ensure the sustenance of QMS processes like Deviation Management, CAPA, CC, Complaints Management, Training Management, Calibration Management & Periodic Reviews. Proactively identify risks and opportunities through a variety of surveillance activities in guidance with the Quality Risk Heat Map elements. Carry our risk assessment and propose risk mitigation in QMS. Communicate and review risks with site and global management to ensure customer, statutory and regulatory requirements are determined, understood and consistently met. Responsible for the functioning of Quality documentation system (ManGo). Responsible for creating, modifying, and approving the document in ManGo related to his/her work. Responsible for maintaining documents in ManGo. Review all site SOP for adequacy, in line with LS QMS. Managing Periodic Review in documentation system. Verify effectiveness of CAPA.Manage change and implement improvement solutions across cross- functional teams.Develop quality objectives that are compatible with the context and strategic direction of the organization, and for communicate these quality objectives as well as the Quality Policy to all within the organization. Prepare and monitor the Weekly Report & Monthly Metrics.Site Lead User (SLU ) for ManGo, TW Audit System & HR4You Learning. Support and participate in the local implementation of global projects or initiatives, change management related to new and revised policies.Follow the EMS / Safety / Compliance norms / rules set by organization. Supporting EHS and EMS implementation as needed.Stay current with standards and procedures, applicable industry regulations and trends.Network and collaborate across all functions with various levels of stakeholders.Handle systemic issues through problem-solving methodologies.Work Location- Peenya OfficeWork Timing- 8am to 5pmWe are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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