• Job Description

  Req#: 202304-110378

  The Position

  Roles & Responsibilities:

  proven ability to work independently and manage multiple competing priorities, as well as demonstrating importance of quality Management. Willingness to drive projects in quality assurance independently aligning various cross function to deliver organizational goal.

  Should be highly self-motivated, organized and achievement driven, with the ability to lead initiatives with responsibility, ownership and aligning all stakeholder

  • Establishment and safeguarding of the local QMS to ensure compliance with internal (Roche Policies, Divisional Quality Standards) and external requirements (ISO 13485, ISO 9001, local regulation) within Operations and other QM-relevant processes.

  • Monitoring of the effectiveness and efficiency of the local QMS together with its continuous improvement by usage of performance indicators and QM-reports as well as the establishment of specific training measures and seek opportunities to continuously improve understanding, performance and quality of complaint documentation, processes and procedures.

  • Providing direction to local management to establish, implement and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards.

  • Interacting across global sites, organizations, levels and groups to accomplish job functions and integrate into global practices.

  • Participating in process improvements and other Corrective and Preventative action programs to ensure compliance with international and local regulations pertaining to QSR, ISO and associated regulatory agencies.

  • In conjunction with local and global Quality Management, developing internal audit program and conducting internal audits and process evaluations to ensure compliance with international and local regulations pertaining to QSR, ISO and associated regulatory agencies.

  • Managing local activities to develop, implement, and maintain policies and procedures essential to assure QS compliance.

  • Interfaces with regulatory agencies and professional organizations to assure quality system remains current and competitive.

  • Maintenance QA-related process, such as training, supply chain management, complaints management aligning with global team meeting requirements of standard.

  • Setting quality guideline for local distribution practice to be implemented and adhered to ensure no risk to product quality during local handling and transportation so as to ensure Product quality is not impaired

  • Handling Quality related Post Market surveillance processes like product Recall, Handling Notifications, Adverse Events.

  • Compilation, review and release of QM manual and other documentable procedures.

  • Responsible for performing various quality audits like internal audits/supplier audit/distributor audit/ managing CAPA and closure.

  • Responsible for leading complex cross-functional process improvement projects, mentoring key Quality process improvement projects, preparing organization for ISO 13485

  • Managing Risk assessment for process and function and review Business continuity plan for key organizational activities

  • Understanding customer need for quality , collaborating with internal team to build capability and for proactively resolving conflicts, delivering Operational Excellence training and value-add sustainable solutions to drive quality projects.

  Experience & Education:

  Graduate /Post Graduate in Micrology/Biotech & ISO 13485 or 9001 certified, NABL trainer will be an added advantage

  8 to 10 years of experience in QMS

  Who we are

  At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

  For more than 60 years, Roche has been committed to making a difference to the lives of people in India. Roche Diagnostics India is the market leader in In-Vitro-Diagnostics, providing diagnostic testing for early detection, evaluation and monitoring of disease. On the product side, the organisation provides a wide range of diagnostic products for customers around distinct disease areas namely diabetes, virology, blood screening, women's health, microbiology, oncology and genomics.

  Roche is an Equal Opportunity Employer.

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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